Single Use Injector NM-401L-0423 (REF N6140230)Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 04953170422621), received between Feb 23, 2022 and Dec 19, 2025 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Mechanical Problem” (10 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 19, 2025Break; Break

  NO NEW ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23850283 ↗
• MalfunctionJan 15, 2025Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THE PLUNGER OF THE SINGLE USE INJECTOR WOULD NOT ENGAGE TO INJECT LIQUID THROUGH THE SHEATH. THE ISSUE WAS OBSERVED DURING AN UNKNOWN PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21161110 ↗
• MalfunctionMay 22, 2024Failure to Deliver; Failure to Deliver

  IT WAS REPORTED THE INJECTOR AND SHEATHSET HAD A NEEDLE DEFECTIVE. THE NEEDLE WAS DISPOSED OF AS IT HAD AVASTIN (CHEMO AGENT) INSIDE. ADDITIONAL INFORMATION RECEIVED STATES: "THESE NEEDLES CONTINUE TO FAIL AT A VERY HIGH RATE. MANY TIMES ONCE THE NEEDLE IS ENGAGED, IT IS NO LONGER POSSIBLE TO PUSH FLUID THROUGH. SOMETIMES THEY ARE THIS WAY OUT OF THE BOX, SOMETIMES IT HAPPENS AFTER PRIMING THE SYSTEM AND THEN RETRACTING THE NEEDLE TO PLACE IT INTO OUR SCOPE. IN THIS SITUATION A LOT OF EXPENSIVE MEDICATION IS WASTED. WE ARE EXTREMELY CAREFUL TO NOT KINK OR TWIST THE CATHETER, BUT THE PROBLEM IS NOT THE CATHETER, IT IS THE INTERNAL MECHANISM OF THE NEEDLE SYSTEM. THIS IS OBVIOUS BECAUSE WHEN THE NEEDLE IS RETRACTED YOU CAN ALWAYS STILL PUSH FLUID THROUGH, EVEN IN THE FAILED NEEDLES. THE PROBLEM OCCURS WHEN THE NEEDLE IS EXTENDED, THE MECHANISM LOCKS." THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19373892 ↗
• MalfunctionJun 7, 2023Infusion or Flow Problem; Infusion or Flow Problem

  AN OLYMPUS EMPLOYEE REPORTED ON BEHALF OF A CUSTOMER, THE SINGLE USE INJECTOR WOULD ONLY INJECT WHEN WITHDRAWN. THE EVENT OCCURRED DURING A THERAPEUTIC FLEXIBLE LARYNGOSCOPY WITH INJECTION OF BOTOX. THE PROCEDURE WAS COMPLETED USING A RE-USABLE FLEXIBLE SHEATH WITH A MAJ-656 (DISPOSABLE NEEDLE). THERE WAS SOME ADDITIONAL TIME ADDED TO THE PROCEDURE DUE TO OPENING THE REPLACEMENT DEVICES. THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED OR PATIENT HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17084232 ↗
• MalfunctionMar 24, 2023Mechanical Problem; Failure to Deliver; No Flow; Mechanical Problem; Failure to Deliver; No Flow

  IT WAS REPORTED, IN CONNECTION WITH A PROCEDURE WHERE THE ESOPHAGUS WAS TO BE BLOCKED, STEROIDS WERE TO BE INJECTED AS AN ADDITIONAL TREATMENT. WHEN THE NEEDLE WAS IN, THE USER COULD NOT GET THE BAG THROUGH AND THEREFORE DID NOT GET AN INJECTION. ANOTHER NEEDLE WAS TRIED (A NEW NEEDLE) , HOWEVER, THE SAME PROBLEM RECURRED. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6) (1ST NEEDLE ) THIS REPORT IS BEING SUBMITTED TO CAPTURE THE SECOND NEEDLE FAILED DURING THE EVENT REPORTED AS CONFIRMED BY THE CUSTOMER DURING A FOLLOW UP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16616445 ↗
• MalfunctionFeb 1, 2023Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED THAT A THERAPEUTIC GASTRIC ULCER BLEEDING CASE WAS BEING DONE. PRIOR TO THE PROCEDURE, TWO INJECTORS WERE OPENED AND INSPECTED BY THE NURSE. NO ISSUES WERE FOUND WHEN THE INJECTORS WERE TESTED. DURING THE PROCEDURE, WHEN THE INJECTOR, WITH THE NEEDLE OUT, WAS INSIDE THE SCOPE, THE NURSE INJECTED THE ADRENALINE SOLUTION; HOWEVER, THE SOLUTION WAS UNABLE TO FLOW. THE SOLUTION WAS STUCK AND COULD NOT FLOW THROUGH THE LUMEN DESPITE MULTIPLE ATTEMPTS. THE NURSE TRIED TO EXAMINE AND TEST THE INJECTOR AFTER TAKING IT OUT OF THE SCOPE, BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING ANOTHER INJECTOR. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16276559 ↗
• MalfunctionFeb 1, 2023Mechanical Jam; Mechanical Jam

  THE CUSTOMER REPORTED THAT A THERAPEUTIC GASTRIC ULCER BLEEDING CASE WAS BEING DONE. PRIOR TO THE PROCEDURE, TWO INJECTORS WERE OPENED AND INSPECTED BY THE NURSE. NO ISSUES WERE FOUND WHEN THE INJECTORS WERE TESTED. DURING THE PROCEDURE, WHEN THE INJECTOR, WITH THE NEEDLE OUT, WAS INSIDE THE SCOPE, THE NURSE INJECTED THE ADRENALINE SOLUTION; HOWEVER, THE SOLUTION WAS UNABLE TO FLOW. THE SOLUTION WAS STUCK AND COULD NOT FLOW THROUGH THE LUMEN DESPITE MULTIPLE ATTEMPTS. THE NURSE TRIED TO EXAMINE AND TEST THE INJECTOR AFTER TAKING IT OUT OF THE SCOPE, BUT THE SAME ISSUE OCCURRED. THE PROCEDURE WAS COMPLETED USING ANOTHER INJECTOR. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16276509 ↗
• MalfunctionJan 18, 2023Failure to Infuse; No Flow; Failure to Infuse; No Flow

  IT WAS REPORTED AT PREPARATION FOR USE (BEFORE PROCEDURE) FOR A THERAPEUTIC GASTRIC ULCER (BLEEDING CASE), THE NURSE INSPECTED, TEST THE INJECTOR AND FOUND NO PROBLEM. HOWEVER, DURING THE PROCEDURE, WHEN THE INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTS THE ADRENALINE SOLUTION AND THE SOLUTION WERE STUCK AND CANNOT FLOW THROUGH THE LUMEN DESPITE TRYING FOR MANY TIMES. THE NURSE TRIED TO EXAMINE AND TEST THE INJECTOR AFTER TAKING IT OUT FROM THE SCOPE, HOWEVER, THE SAME ISSUE TRANSPIRED. A SECOND INJECTOR WAS OPENED AND WAS USED TO CONTINUE THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AND THE PATIENT WAS REPORTED TO BE IN GOOD STATUS. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16192693 ↗
• MalfunctionOct 22, 2022Mechanical Problem; No Flow; Mechanical Problem; No Flow

  IT WAS REPORTED DURING A THERAPEUTIC ENDOSCOPY PROCEDURE, THE NURSE OPENED AND INSERTED THE NEEDLE NM-401L-0423 INTO THE INSTRUMENT CHANNEL AND WHEN TRIED TO INJECT LIQUID, IT COULD NOT BE INJECTED AS "IT WAS COVERED " PER THE REPORTER. THE SAME DEVICE WAS NOT USED TO COMPLETE THE PROCEDURE. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656379 ↗
• MalfunctionOct 13, 2022Mechanical Problem; Failure to Infuse; Mechanical Problem; Failure to Infuse

  IT WAS REPORTED AT PREPARATION FOR USE (BEFORE PROCEDURE) FOR A THERAPEUTIC GASTRIC ULCER CASE, THE NURSE INSPECTED THE INJECTOR AND USED THE ADRENALINE SOLUTION TO TEST THE INJECTION AND FOUND NO PROBLEM. HOWEVER, DURING THE PROCEDURE, WHEN THE INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTS THE ADRENALINE SOLUTION AND THE SOLUTION GOT STUCK AND CANNOT FLOW THROUGH THE LUMEN DESPITE TRYING FOR MANY TIMES. THE NURSE TRIED TO EXAMINE AND TEST THE INJECTOR AFTER TAKING IT OUT FROM THE SCOPE, HOWEVER, THE SAME ISSUE TRANSPIRED. A SECOND INJECTOR (NM-401L-0423 LOT# 21K) WAS OPENED AND USED TO CONTINUE THE PROCEDURE BUT THE SAME ISSUE OCCURRED ( THE NURSE EXAMINES AND TEST AGAIN THE SECOND INJECTOR AFTER TAKING IT OUT FROM THE SCOPE, BUT THE NEEDLE CANNOT BE RETRACTED AND DEPLOYED ). THE INTENDED PROCEDURE WAS COMPLETED BY USING ANOTHER SIMILAR INJECTION NEEDLE (INJECTOR (NM-401L-0423 WITH LOT NUMBER NOT PROVIDED ) AND THE PATIENT WAS REPORTED TO BE IN GOOD STATUS. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT INCLUDES TWO (2) REPORTS: ( 2 FAILED INJECTOR SAME MODEL WITH DIFFERENT LOT NUMBER ). REPORT WITH PATIENT IDENTIFIER(B)(6) ( M

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600757 ↗
• MalfunctionOct 13, 2022Mechanical Problem; Failure to Infuse; Mechanical Problem; Failure to Infuse

  IT WAS REPORTED AT PREPARATION FOR USE (BEFORE PROCEDURE) FOR A THERAPEUTIC GASTRIC ULCER CASE, THE NURSE INSPECTED THE INJECTOR AND USED THE ADRENALINE SOLUTION TO TEST THE INJECTION AND FOUND NO PROBLEM. HOWEVER, DURING THE PROCEDURE, WHEN THE INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTS THE ADRENALINE SOLUTION AND THE SOLUTION GOT STUCK AND CANNOT FLOW THROUGH THE LUMEN DESPITE TRYING FOR MANY TIMES. THE NURSE TRIED TO EXAMINE AND TEST THE INJECTOR AFTER TAKING IT OUT FROM THE SCOPE, HOWEVER, THE SAME ISSUE TRANSPIRED. A SECOND INJECTOR (NM-401L-0423 LOT# 21K) WAS OPENED AND USED TO CONTINUE THE PROCEDURE BUT THE SAME ISSUE OCCURRED. THE INTENDED PROCEDURE WAS COMPLETED BY USING ANOTHER SIMILAR INJECTION NEEDLE (INJECTOR (NM-401L-0423 WITH LOT NUMBER NOT PROVIDED ) AND THE PATIENT WAS REPORTED TO BE IN GOOD STATUS. THERE WAS NO PATIENT HARM, NO USER INJURY REPORTED DUE TO THE EVENT. THIS EVENT INCLUDES TWO (2) REPORTS: ( 2 FAILED INJECTOR SAME MODEL WITH DIFFERENT LOT NUMBER ). REPORT WITH PATIENT IDENTIFIER (B)(6) ( MODEL NM-401L-0423, LOT # 0ZK )- FIRST INJECTOR . REPORT WITH PATIENT IDENTIFIER (B)(6) ( MODEL NM-401L-0423, LOT # 21K ) - SECOND INJECTOR. T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15600711 ↗
• MalfunctionJul 15, 2022Break; Retraction Problem; Break; Retraction Problem

  A USER FACILITY REPORTED TO OLYMPUS, THE SINGLE USE INJECTOR WAS UNABLE TO INJECT WHEN NEEDLE WAS OUT. THE EVENT OCCURRED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE INJECTOR WAS TESTED IN AND OUT OF THE PATIENT BUT SHOWED THE SAME RESULTS. ACCORDING TO THE REPORT, INJECTION WAS POSSIBLE WHEN THE NEEDLE WAS RETRACTED, AND A 2ND NEEDLE WAS USED WITH THE SAME RESULT. THERE WAS NO REPORT OF PATIENT HARM OR USER INJURY ASSOCIATED WITH THIS EVENT. THIS COMPLAINT IS RELATED TO PATIENT IDENTIFIER (B)(6) FOR THE FIRST DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15029892 ↗
• MalfunctionJun 28, 2022Mechanical Problem; Failure to Infuse; Mechanical Problem; Failure to Infuse

  AS REPORTED, THE NURSE INSPECTS THE SECOND INJECTOR AND USE THE ADRENALINE SOLUTION TO TEST THE INJECTION AND THERE WAS NO PROBLEM. DURING THE PROCEDURE WHEN THE SECOND INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTS THE ADRENALINE SOLUTION AND AGAIN THE SOLUTION GOT STUCK AND CANNOT FLOW THROUGH THE LUMEN DESPITE TRYING FOR MANY TIMES. THE NURSE HAS ALSO TRIED TO EXAMINE AND TEST THE SECOND INJECTOR AFTER TAKING IT OUT FROM THE SCOPE, BUT THE SAME ISSUE TRANSPIRED. THE SAME PROBLEM OCCURRED FOR THE FIRST INJECTOR (COMPLAINT REF.(B)(4) THE INTENDED PROCEDURE (BLEEDING CASE GASTRIC ULCER) WAS COMPLETED BY USING ANOTHER SIMILAR INJECTION NEEDLE . THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. PATIENT IS IN GOOD STATUS. THIS REPORT IS FOR THE SECOND INJECTION NEEDLE UNIT LOT 16K. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6) (1ST INJECTION NEEDLE UNIT) LOT OZK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14839189 ↗
• MalfunctionJun 28, 2022Mechanical Problem; Failure to Infuse; Mechanical Problem; Failure to Infuse

  AS REPORTED, BEFORE THE PROCEDURE THE NURSE INSPECTS THE INJECTOR AND USE THE ADRENALINE SOLUTION TO TEST THE INJECTION AND THERE WAS NO PROBLEM. HOWEVER, DURING THE PROCEDURE, WHEN THE INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTS THE ADRENALINE SOLUTION AND THE SOLUTION GOT STUCK AND CANNOT FLOW THROUGH THE LUMEN DESPITE TRYING FOR MANY TIMES. THE NURSE HAS ALSO TRIED TO EXAMINE AND TEST THE INJECTOR AFTER TAKING IT OUT FROM THE SCOPE, BUT THE SAME ISSUE TRANSPIRED. THEREFORE, A SECOND INJECTOR WAS OPENED AND USED TO CONTINUE THE PROCEDURE. THE INTENDED PROCEDURE (BLEEDING CASE GASTRIC ULCER) WAS COMPLETED BY USING ANOTHER SIMILAR INJECTION NEEDLE . THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THIS REPORT IS FOR THE FIRST INJECTION NEEDLE UNIT LOT OZK. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6) (SECOND INJECTION NEEDLE UNIT) LOT 16K.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14839133 ↗
• MalfunctionMay 20, 2022Mechanical Problem; Mechanical Problem

  AS REPORTED, DURING THE PROCEDURE WHEN THE INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTS THE ADRENALINE SOLUTION AND THE SOLUTION WERE STUCK AND CANNOT FLOW THROUGH THE LUMEN DESPITE TRYING FOR MANY TIMES. HOWEVER; THE SOLUTION CAN FLOW THROUGH THE LUMEN WHEN THE NURSE TESTS THE INJECTOR (WITH NEEDLE IN). FURTHERMORE, THE NURSE HAS ALSO TRIED TO EXAMINE AND TEST THE INJECTOR AGAIN AFTER TAKING IT OUT FROM THE SCOPE, BUT THE SAME ISSUE TRANSPIRED. A SECOND INJECTOR AND THIRD INJECTOR WERE OPENED AND USED TO CONTINUE THE PROCEDURE BUT THE SAME ISSUE OCCURRED. THE INTENDED PROCEDURE (BLEEDING CASE GASTRIC ULCER) WAS COMPLETED BY USING ANOTHER SIMILAR INJECTION NEEDLE (NEEDLE MASTER, NM-610L-0423 WITH LOT NUMBER NOT PROVIDED) AND THE PATIENT WAS IN A GOOD STATUS. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THE SAME ISSUE OCCURRED ON THREE INJECTION NEEDLE ON THE SAME LOT (LOT NO. 13K). THIS REPORT IS FOR THE SECOND INJECTION NEEDLE. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6) (FIRST INJECTION NEEDLE UNIT ) AND (B)(6) (THIRD INJECTION NEEDLE UNIT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14460645 ↗
• MalfunctionMay 20, 2022Mechanical Problem; Mechanical Problem

  AS REPORTED, DURING THE PROCEDURE WHEN THE INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTS THE ADRENALINE SOLUTION AND THE SOLUTION WERE STUCK AND CANNOT FLOW THROUGH THE LUMEN DESPITE TRYING FOR MANY TIMES. HOWEVER, THE SOLUTION CAN FLOW THROUGH THE LUMEN WHEN THE NURSE TESTS THE INJECTOR (WITH NEEDLE IN). FURTHERMORE, THE NURSE HAS ALSO TRIED TO EXAMINE AND TEST THE INJECTOR AGAIN AFTER TAKING IT OUT FROM THE SCOPE, BUT THE SAME ISSUE TRANSPIRED. A SECOND INJECTOR AND THIRD INJECTOR WERE OPENED AND USED TO CONTINUE THE PROCEDURE BUT THE SAME ISSUE OCCURRED. THE INTENDED PROCEDURE (BLEEDING CASE GASTRIC ULCER) WAS COMPLETED BY USING ANOTHER SIMILAR INJECTION NEEDLE (NEEDLE MASTER, NM-610L-0423 WITH LOT NUMBER NOT PROVIDED) AND THE PATIENT WAS IN A GOOD STATUS. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THE SAME ISSUE OCCURRED ON THREE (3) INJECTION NEEDLE ON THE SAME LOT (LOT NO. 13K). THIS REPORT IS FOR THE FIRST INJECTION NEEDLE UNIT. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6) (SECOND INJECTION NEEDLE UNIT) AND (B)(6) (THIRD INJECTION NEEDLE UNIT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14460533 ↗
• MalfunctionMay 20, 2022Mechanical Problem; Mechanical Problem

  AS REPORTED, DURING THE PROCEDURE WHEN THE INJECTOR (WITH NEEDLE OUT) WAS INSIDE THE SCOPE, THE NURSE INJECTS THE ADRENALINE SOLUTION AND THE SOLUTION WERE STUCK AND CANNOT FLOW THROUGH THE LUMEN DESPITE TRYING FOR MANY TIMES. HOWEVER, THE SOLUTION CAN FLOW THROUGH THE LUMEN WHEN THE NURSE TESTS THE INJECTOR (WITH NEEDLE IN). FURTHERMORE, THE NURSE HAS ALSO TRIED TO EXAMINE AND TEST THE INJECTOR AGAIN AFTER TAKING IT OUT FROM THE SCOPE, BUT THE SAME ISSUE TRANSPIRED. A SECOND INJECTOR AND THIRD INJECTOR WERE OPENED AND USED TO CONTINUE THE PROCEDURE BUT THE SAME ISSUE OCCURRED. THE INTENDED PROCEDURE (BLEEDING CASE GASTRIC ULCER) WAS COMPLETED BY USING ANOTHER SIMILAR INJECTION NEEDLE (NEEDLE MASTER, NM-610L-0423 WITH LOT NUMBER NOT PROVIDED) AND THE PATIENT WAS IN A GOOD STATUS. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY REPORTED. THE SAME ISSUE OCCURRED ON THREE (3) INJECTION NEEDLE ON THE SAME LOT (LOT NO. 13K). THIS REPORT IS FOR THE THIRD INJECTION NEEDLE. THIS REPORT IS RELATED TO A REPORT WITH PATIENT IDENTIFIER (B)(6) (FIRST INJECTION NEEDLE UNIT ) AND (B)(6) (SECOND INJECTION NEEDLE UNIT).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14460417 ↗
• MalfunctionMar 8, 2022Mechanical Problem; No Flow; Mechanical Problem; No Flow

  IT WAS REPORTED THAT DURING A GASTRIC ENDOSCOPY THERAPEUTIC PROCEDURE, WHEN THE NEEDLE WAS "OUT" THEY COULD NOT INJECT, WHEN THE NEEDLE WAS "IN" THEY COULD INJECT. THE INTENDED PROCEDURE HOWEVER, WAS ABLE TO BE COMPLETED. ACCORDING TO THE REPORTER, IT DELAYED THE PROCEDURE MOMENTARILY BUT DID NOT IMPACT THE OUTCOME OF THE PROCEDURE. THERE WAS NO PATIENT HARM OR INJURY REPORTED DUE TO THE EVENT. NO USER INJURY WAS REPORTED. DEVICE EVALUATION FOUND UNABLE TO INJECT FLUID WHEN NEEDLE WAS EXTENDED, HOWEVER, FLUID FROM THE SYRINGE WAS ABLE TO PASS THROUGH WHEN IN A PULLED POSITION. THE REPORTED CUSTOMER ISSUE WAS REPLICATED. THIS REPORT IS BEING SUBMITTED FOR UNABLE TO INJECT FLUID WHEN NEEDLE WAS EXTENDED FOUND DURING DEVICE EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13691483 ↗
• MalfunctionFeb 23, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED LIQUID DID NOT FLOW THROUGH THE SUBJECT DEVICE WHEN THE PHYSICIAN ATTEMPTED TO INJECT LIQUID INTO THE MUCOUS MEMBRANE DURING A PROCEDURE. THE PHYSICIAN REMOVED THE NEEDLE FROM THE SCOPE AND ATTEMPTED TO INJECT OUTSIDE OF THE PATIENT, AND NO LIQUID FLOWED THROUGH THE NEEDLE. THE DEVICE WAS REPLACED WITH ANOTHER INJECTION NEEDLE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS ISSUE HAPPENED WITH TWO DEVICES. THIS REPORT IS BEING SUBMITTED FOR THE ISSUE WITH THE SECOND NM-401L-0423, WITH PATIENT IDENTIFIER (B)(6) . THE ISSUE WITH THE FIRST NM-401L-0423 WAS SUBMITTED UNDER THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588598 ↗
• MalfunctionFeb 23, 2022Infusion or Flow Problem; Infusion or Flow Problem

  THE CUSTOMER REPORTED LIQUID DID NOT FLOW THROUGH THE SUBJECT DEVICE WHEN THE PHYSICIAN ATTEMPTED TO INJECT LIQUID INTO THE MUCOUS MEMBRANE DURING AN ENDOSCOPIC MUCOSAL RESECTION (EMR) PROCEDURE. THE PHYSICIAN REMOVED THE NEEDLE FROM THE SCOPE AND ATTEMPTED TO INJECT OUTSIDE OF THE PATIENT, AND NO LIQUID FLOWED THROUGH THE NEEDLE. THE DEVICE WAS REPLACED WITH ANOTHER INJECTION NEEDLE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT HARM OR USER INJURY REPORTED DUE TO THE EVENT. THIS ISSUE HAPPENED WITH TWO DEVICES. THIS REPORT IS BEING SUBMITTED FOR THE ISSUE WITH THE FIRST NM-401L-0423, WITH PATIENT IDENTIFIER (B)(6). THE ISSUE WITH THE SECOND NM-401L-0423 IS BEING SUBMITTED UNDER THE MEDWATCH WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13588494 ↗