NIPRO LUER ADAPTER LM+20GRecalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10383790002391), received between Oct 7, 2024 and Aug 27, 2025 — classified as 7 injuries, 13 malfunctions.

The most frequently reported specific device problem is “Break” (20 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.

• InjuryAug 27, 2025Break; Break

  CLINICAL EDUCATOR STATED THAT SEVERAL NEEDLES BREAK OFF INTO CATHETER LUMENS WHEN OBTAINING LAB WORK ON PATIENTS. IT'S NOT THE ACTUAL NEEDLE. IT'S THE TIP OF VACUTAINER THAT GOES INSIDE THE CATHETER LUMEN THAT GETS STUCK INSIDE AND BREAKS OFF WHEN TRYING TO REMOVE. CLINICAL EDUCATOR ALSO MENTIONED THAT A PATIENT WAS INVOLVED AND REQUIRED MEDICAL INTERVENTION TO REPLACE THE CATHETER.

  Patient problems: Insufficient Information

  MAUDE report 22909450 ↗
• MalfunctionAug 27, 2025Break; Break

  CLINICAL EDUCATOR STATED THAT SEVERAL NEEDLES BREAK OFF INTO CATHETER LUMENS WHEN OBTAINING LAB WORK ON PATIENTS. IT'S NOT THE ACTUAL NEEDLE; IT'S THE TIP OF VACUTAINER THAT GOES INSIDE THE CATHETER LUMEN THAT GETS STUCK INSIDE AND BREAKS OFF WHEN TRYING TO REMOVE. CLINICAL EDUCATOR ALSO MENTIONED THAT A PATIENT WAS INVOLVED AND REQUIRED MEDICAL INTERVENTION TO REPLACE THE CATHETER.

  Patient problems: Insufficient Information

  MAUDE report 22909385 ↗
• InjuryDec 8, 2024Break; Break

  THE REPORTER NOTED THE FOLLOWING: "A CLINICAL MANAGER REPORTED TO FRESENIUS MEDICAL CARE VIA EMAIL THAT A PATIENT CARE TECHNICIAN USED THE LUER ADAPTER (LUER ADAPTER, 20GX3/4 1BX/100EA) IN PATIENT CVC WITH VACUTAINER TO DRAW HG. UPON REMOVAL, THE ADAPTER BROKE OFF IN THE CVC ARTERIAL LIMB AND WAS UNABLE TO BE REMOVED. THE PATIENT WAS SENT OUT TO ACCESS CENTER FOR CVC EXCHANGE." NO INJURY TO PATIENT, BUT DID HAVE TO RECEIVE SURGICAL REPLACEMENT OF CVC DUE TO INCIDENT. PATIENT RETURNED TO CLINIC SAME DAY AND RECEIVED FULL DIALYSIS TREATMENT AFTER CVC PROCEDURE.

  Patient problems: Insufficient Information

  MAUDE report 20875413 ↗
• MalfunctionDec 8, 2024Break; Break

  IT WAS REPORTED TO CUSTOMER SERVICE OF FRESENIUS MEDICAL CARE THAT THE END OF THE ADAPTER THAT GOES INTO THE PATIENT'S CVC BROKE OFF IN THE CVC LUMEN. THIS OCCURRED AT THE PATIENT'S HOME WHEN THE CARE PARTNER/WIFE WAS OBTAINING MONTHLY LAB WORK. THE END OF THE LUMEN THAT GOES INTO THE PT'S CATHETER GOT STUCK IN THE END OF THE PT'S LUMEN. CARE PARTNER REPORTS THAT SHE HAD TO WIGGLE IT BACK AND FORTH FOR SEVERAL MINUTES BEFORE IT RELEASED. NO INJURY TO THE PATIENT. IT DID NOT BREAK OFF AS PREVIOUSLY THOUGHT.

  Patient problems: Insufficient Information

  MAUDE report 20875287 ↗
• MalfunctionDec 8, 2024Break; Break

  IT WAS REPORTED TO CUSTOMER SERVICE OF FRESENIUS MEDICAL CARE THAT THE END OF THE ADAPTER THAT GOES INTO THE PATIENT'S CVC BROKE OFF IN THE CVC LUMEN. THIS OCCURRED AT THE PATIENT'S HOME WHEN THE CARE PARTNER/WIFE WAS OBTAINING MONTHLY LAB WORK. THE END OF THE LUMEN THAT GOES INTO THE PT'S CATHETER GOT STUCK IN THE END OF THE PT'S LUMEN. CARE PARTNER REPORTS THAT SHE HAD TO WIGGLE IT BACK AND FORTH FOR SEVERAL MINUTES BEFORE IT RELEASED. NO INJURY TO THE PATIENT. IT DID NOT BREAK OFF AS PREVIOUSLY THOUGHT.

  Patient problems: Insufficient Information

  MAUDE report 20875284 ↗
• MalfunctionDec 8, 2024Break; Break

  THE CUSTOMER REPORTED, THE FOLLOWING: "I AM REACHING OUT TO YOU IN REGARD TO NIPRO MEDICAL LUER ADAPTER PN#: (B)(4), REF#: LM+20G. IN PARTICULAR, LOT'S#: 22K29A, 22J11B, 22J14B. I HAVE ALSO, COME ACROSS SOME FAILURES (BREAKAGE) OF THIS PRODUCT". THE REPORTER BELIEVED, THE FIRST ISSUE NOTED, WAS SOMETIME IN MARCH 2024, BUT WERE UNABLE TO SPECIFY A DATE. THEY ALSO NOTED, THAT IT IS UNKNOWN, HOW MANY LUER ADAPTERS ARE IMPACTED. "THE ADAPTERS ARE GETTING STUCK IN THE LUMENS OF THE CVC. RESULTING, IN PATIENT BEING SENT TO THE EMERGENCY ROOM. AND HAVING THE CVC REPLACED OR BROKEN PART REMOVED FROM LUMEN BY A VASCULAR SURGEON. PATIENTS ARE MISSING DIALYSIS TREATMENT". LOT'S#: IN QUESTION: 22K29A, 22J11B, 22J14B, 23B27B, 22K09A.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 20875261 ↗
• MalfunctionDec 8, 2024Break; Break

  THE CUSTOMER REPORTED THE FOLLOWING : "I AM REACHING OUT TO YOU IN REGARD TO NIPRO MEDICAL LUER ADAPTER PN#367290 REF# LM+20G , IN PARTICULAR, LOT # 'S 22K29A / 22J11B / 22J14B. I HAVE ALSO COME ACROSS SOME FAILURES (BREAKAGE) OF THIS PRODUCT." THE REPORTER BELIEVED THE FIRST ISSUE NOTED WAS SOMETIME IN MARCH 2024, BUT WERE UNABLE TO SPECIFY A DATE. THEY ALSO NOTED THAT IT IS UNKNOWN HOW MANY LUER ADAPTERS ARE IMPACTED. "THE ADAPTERS ARE GETTING STUCK IN THE LUMENS OF THE CVC RESULTING IN PATIENT BEING SENT TO THE EMERGENCY ROOM AND HAVING THE CVC REPLACED OR BROKEN PART REMOVED FROM LUMEN BY A VASCULAR SURGEON. PATIENTS ARE MISSING DIALYSIS TREATMENT." LOT#S IN QUESTION: 22K29A, 22J11B, 22J14B, 23B27B, 22K09A.

  Patient problems: Insufficient Information

  MAUDE report 20875252 ↗
• MalfunctionDec 8, 2024Break; Break

  THE REPORTER NOTED THE FOLLOWING: "ADAPTERS HAVE BROKEN OFF INSIDE 2 CATHETER HUBS AND 1 FISLTULA NEEDLE LINE WHEN ATEMPTING TO REMOVE AFTER BLOOD DRAWS. FLOAT STAFF AT UNIT ON THESE DAYS REPORT SEEING THIS HAPPEN AT OTHER UNITS IN THE AREA. UNSURE IF THOSE EVENTS WERE REPORTED.". THE CUSTOMER NOTED THEY HAD 2 LOTS: 23B27B, 22K09A. HOWEVER, THEY WERE UNSURE WHICH 1 HAD THE ISSUE. THEY REPORTED NO INJURY TO PATIENTS (3) AS THEY WERE ABLE TO RETRIEVE THE BROKEN FRAGMENTS. ALSO, THE REPORTER NOTED THE FOLLOWING: "STAFF WORKING IN OUR FLOAT POOL REPORTED TO ME THAT THEY HAVE SEEN THIS HAPPENING AT OTHER CLINICS THAT THEY WORK AT."

  Patient problems: Insufficient Information

  MAUDE report 20875047 ↗
• MalfunctionDec 7, 2024Break; Break

  IT WAS REPORTED TO FRESENIUS MEDICAL CARE BY A REGISTERED NURSE THAT MULTIPLE LUER ADAPTER BREAKING AWAY FROM VACUTAINER AND HAVING REMOVED FROM DIALYSIS ACCESS. THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION ON 12-NOV-2024: "THE INCIDENT OCCURRED ON (B)(6) 2024 AT CLINIC (B)(6) AND (B)(6) 2024 AT CLINIC (B)(6). ON (B)(6) 2024, THERE WERE 3 OF THE ADAPTERS BREAK IN THE DIALYSIS ACCESS."

  Patient problems: Insufficient Information

  MAUDE report 20874161 ↗
• InjuryDec 7, 2024Break; Break

  IT WAS REPORTED TO FRESENIUS MEDICAL CARE BY A REGISTERED NURSE THAT MULTIPLE LUER ADAPTER BREAKING AWAY FROM VACUTAINER AND HAVING REMOVED FROM DIALYSIS ACCESS. THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION ON (B)(6) 2024: "THE INCIDENT OCCURRED ON (B)(6) 2024 AT CLINIC (B)(6) AND (B)(6) 2024 AT CLINIC (B)(6). ON (B)(6) 2024, THERE WERE 3 OF THE ADAPTERS BREAK IN THE DIALYSIS ACCESS.".

  Patient problems: Insufficient Information

  MAUDE report 20874141 ↗
• MalfunctionDec 7, 2024Break; Break

  IT WAS REPORTED TO FRESENIUS MEDICAL CARE BY AN ADMINISTRATIVE ASSISTANT THAT THE END PIECE RELEASES AND GETS STUCK WHEN USING FOR BLOOD DRAWS. BLOOD DRAWS IN (B)(6) 2024. (SEVERAL PATIENTS OVER THE COURSE OF 2 DAYS). CLINIC ASKED FOR THEIR STAFF'S PREFERRED ADAPTERS MADE BY A DIFFERENT MANUFACTURER FOR THE FOLLOWING ORDER FROM SPECTRA FOR THE FOLLOWING MONTH. THEY DISCONTINUED USING THE NIPRO BRAND IMMEDIATELY. THIS MONTH, THEY RECEIVED 2 MORE BOXES, WHICH THEN PROMPTED THEIR COMPLAINT. NO INJURY TO PATIENT, JUST DELAYED COMPLETION OF TREATMENT DUE TO HAVING TO GET A DOCTOR TO TRAVEL HERE TO REMOVE THE "CAP" LODGED IN CATHETER HUB. ALSO WAS STUCK IN FISTULA TUBING LINE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20873878 ↗
• InjuryDec 7, 2024Break; Break

  IT WAS REPORTED TO FRESENIUS MEDICAL CARE BY AN ADMINISTRATIVE ASSISTANT THAT THE END PIECE RELEASES AND GETS STUCK WHEN USING FOR BLOOD DRAWS. BLOOD DRAWS IN (B)(6) 2024. (SEVERAL PATIENTS OVER THE COURSE OF 2 DAYS). CLINIC ASKED FOR THEIR STAFF'S PREFERRED ADAPTERS MADE BY A DIFFERENT MANUFACTURER FOR THE FOLLOWING ORDER FROM SPECTRA FOR THE FOLLOWING MONTH. THEY DISCONTINUED USING THE NIPRO BRAND IMMEDIATELY. THIS MONTH, THEY RECEIVED 2 MORE BOXES, WHICH THEN PROMPTED THEIR COMPLAINT. NO INJURY TO PATIENT, JUST DELAYED COMPLETION OF TREATMENT DUE TO HAVING TO GET A DOCTOR TO TRAVEL HERE TO REMOVE THE "CAP" LODGED IN CATHETER HUB. ALSO WAS STUCK IN FISTULA TUBING LINE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20873859 ↗
• MalfunctionDec 7, 2024Break; Break

  IT WAS REPORTED TO FRESENIUS MEDICAL CARE BY CLINIC MANAGER THAT: LUER ADAPTER BREAKING OFF IN PATIENT CATHETER HUB, THIS WAS A SECOND OCCURRENCE FOR THIS PATIENT IN ONE WEEK AND RESETED IN HAVING TO CATHETER EXCHANGE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20873840 ↗
• InjuryDec 7, 2024Break; Break

  IT WAS REPORTED, TO (B)(6) BY CLINIC MANAGER THAT, LUER ADAPTER BREAKING OFF IN PATIENT CATHETER HUB. THIS WAS A SECOND OCCURRENCE, FOR THIS PATIENT IN ONE WEEK. AND RESETED IN HAVING TO CATHETER EXCHANGE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20873829 ↗
• MalfunctionDec 7, 2024Break; Break

  IT WAS REPORTED TO FRESENIUS MEDICAL CARE BY A REGISTERED NURSE THAT, THE NIPRO ADAPTER BREAK AT THE NECK AND GET STACK IN PATIENT CATHETER EXIT SITES AND NEEDLES. TURNING CLOCKWISE MAKES IT GO DIPPER AND ANTICLOCKWISE HARDER TO PULL, THEY BREAKING AT THE NECK.

  Patient problems: Insufficient Information

  MAUDE report 20873789 ↗
• MalfunctionDec 7, 2024Break; Break

  IT WAS REPORTED TO FRESENIUS MEDICAL CARE BY A REGISTERED NURSE THAT, THE NIPRO ADAPTER BREAK AT THE NECK AND GET STACK IN PATIENT CATHETER EXIT SITES AND NEEDLES. TURNING CLOCKWISE MAKES IT GO DIPPER AND ANTICLOCKWISE HARDER TO PULL, THEY BREAKING AT THE NECK.

  Patient problems: Insufficient Information

  MAUDE report 20873771 ↗
• MalfunctionNov 20, 2024Break; Break

  THE REPORTER NOTED THAT SINCE SWITCHING TO THE NEW VACUTAINERS, THE DPC STAFF HAVE HAD A HIGH RATE OF VACUTAINERS BREAKING OFF IN CATHETER LUMENS DURING LAB DRAWS. THE LATEST ISSUE CAUSED A PATIENT TO NEED EMERGENCY INTERVENTIONS AND MISSED A TREATMENT. THE PATIENT HAD TO BE SENT OUT FOR EMERGENCY TREATMENT. THERE WAS A TOTAL OF FIVE LUER ADAPTERS THAT BROKE OFF IN A PERIOD OF ONE WEEK. THE PATIENT IS CURRENTLY DOING GOOD AND IS BACK IN THE CLINIC FOR TREATMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20741105 ↗
• InjuryNov 6, 2024Break; Break

  THE REPORTER NOTED THAT SINCE SWITCHING TO THE NEW VACUTAINERS, THE DPC STAFF HAVE HAD A HIGH RATE OF VACUTAINERS BREAKING OFF IN CATHETER LUMENS DURING LAB DRAWS. THE LATEST ISSUE CAUSED A PATIENT TO NEED EMERGENCY INTERVENTIONS AND MISSED A TREATMENT. THE PATIENT HAD TO BE SENT OUT FOR EMERGENCY TREATMENT. THERE WAS A TOTAL OF FIVE LUER ADAPTERS THAT BROKE OFF IN A PERIOD OF ONE WEEK. THE PATIENT IS CURRENTLY DOING GOOD AND IS BACK IN THE CLINIC FOR TREATMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20622404 ↗
• InjuryOct 7, 2024Break; Break

  THE REPORTER NOTED THE FOLLOWING: "LUER ADAPTERS ARE BREAKING OFF IN THE CHEST CATHETERS USED TO DIALYZE THE PATIENT. WHEN WE TRY TO REMOVE THE PLASTIC, IT GETS STUCK AND WHEN WE ATTEMPT TO REMOVED THE PLASTIC THEN IT IS COMMONLY BREAKING IN THE CATHETER. THIS HAS HAPPENED 5 TIMES THIS WEEK (B)(6) 2024 AND HAS LED TO 1 PATIENT BEING SENT TO THE ER BECAUSE WE COULDN'T REMOVE THE PLASTIC." DATES OF OCCURRENCES: 1 ON MONDAY (B)(6) 2 ON TUESDAY (B)(6) 3 ON THURSDAY (B)(6) ONLY ONE OCCURRENCE ON (B)(6) RESULTED IN PATIENT GOING TO HOSPITAL TO HAVE CVC REPLACED. THE REPORTER DOES NOT HAVE FURTHER UPDATES ON THE PATIENT. THE REPORTER STATED THAT ALL OF THESE OCCURRED WHILE ATTEMPTED TO DRAW LABS FROM CVC. THEY WERE SLIGHTLY TWISTING OFF THE ADAPTER WHEN IT BROKE OFF LEAVING PART OF THE ADAPTER ATTACHED TO THE PATIENT'S CVC.

  Patient problems: Foreign Body In Patient

  MAUDE report 20392819 ↗
• MalfunctionOct 7, 2024Break; Break

  THE REPORTER NOTED THE FOLLOWING: "LUER ADAPTERS ARE BREAKING OFF IN THE CHEST CATHETERS USED TO DIALYZE THE PATIENT. WHEN WE TRY TO REMOVE THE PLASTIC IT GETS STUCK AND WHEN WE ATTEMPT TO REMOVE THE PLASTIC THEN IT IS COMMONLY BREAKING IN THE CATHETER. THIS HAS HAPPENED 5 TIMES THIS WEEK ((B)(6) 2024 TO (B)(6) 2024) AND HAS LED TO 1 PATIENT BEING SENT TO THE ER BECAUSE WE COULDN'T REMOVE THE PLASTIC." DATES OF OCCURRENCES: 1 ON (B)(6) . 2 ON (B)(6) . 3 ON(B)(6) . ONLY ONE OCCURRENCE ON(B)(6) RESULTED IN PATIENT GOING TO HOSPITAL TO HAVE CVC REPLACED. THE REPORTER DOES NOT HAVE FURTHER UPDATES ON THE PATIENT. THE REPORTER STATED THAT ALL OF THESE OCCURRED WHILE ATTEMPTED TO DRAW LABS FROM CVC. THEY WERE SLIGHTLY TWISTING OFF THE ADAPTER WHEN IT BROKE OFF LEAVING PART OF THE ADAPTER ATTACHED TO THE PATIENT'S CVC.

  Patient problems: Foreign Body In Patient

  MAUDE report 20392642 ↗