Alaris MS3500-15Recalls & reported problems

Summary

The FDA's MAUDE database contains 158 adverse event reports that list this exact device (DI 10885403222610), received between Aug 6, 2018 and Apr 8, 2026 — classified as 2 injuries, 156 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (69 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 158 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Leak/Splash; Separation Problem

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24820769 ↗
• MalfunctionMar 25, 2026

  BD SECONDARY TUBING SET (REF MS3500-15): THE TUBING BROKE AWAY FROM THE CHAMBER ALLOWING MEDICATION TO SPILL OUT FROM BOTTOM OF CHAMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24686988 ↗
• MalfunctionApr 28, 2025Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS UNDER INFUSING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM CLINICIANS REPORT THAT VOLUME LEFT OVER IS HAPPENING WITH ¿ALL MEDICATIONS¿, USUALLY THERE IS AN EXTRA 20ML SITTING IN THE IV BAG. IF IT IS A 50ML IV BAG THERE IS 10-15ML LEFT IN THE IV BAG WHEN THE INFUSION SHOULD HAVE COMPLETED. UNDER INFUSION ¿ IRON, SECONDARY IV SET ONE CLINICIAN RECALLED AN UNDER INFUSION OF IRON ON A SECONDARY IV SET. THE SECONDARY IV BAG WAS NOT EMPTY, BUT THE PUMP CONVERTED BACK TO THE PRIMARY IV FLUID. THE CLINICIAN HAD TO GO BACK TO PROGRAM ANOTHER 7ML TO EMPTY THE IV IRON BAG. HOWEVER, WHEN THEY ATTEMPTED TO PROGRAM THIS, THE PUMP WAS TRYING TO ¿RUN IT FASTER AND BOLUS IT¿. ESSENTIALLY, WHEN THE CLINICIAN WENT TO ADD MORE VOLUME, IT INCREASED THE RATE. THEREFORE, THE CLINICIAN HAD TO START THE INFUSION AGAIN AS IF IT WAS A WHOLE NEW IV IRON BAG, THEN IMMEDIATELY STOP THE INFUSION SO THEY COULD PROGRAM IT AS JUST ANOTHER 7ML AT THE APPROPRIATE RATE. THE CLINICIANS ARE WORRIED THAT IN THIS SCENARIO SOMEONE MAY NOT NOTICE THE RATE INCREASE OR THEY MAY FORGET TO STOP AND CHANGE THE RATE, THEREFORE THE REMA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21919068 ↗
• MalfunctionJan 15, 2025Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET HAD UNDER INFUSED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING. IT WAS REPORTED BY THE CUSTOMER THAT THEY DON'T DRIP AS FAST AS THEY STATE THEY DO. USUALLY TAKES 30 MINUTES, BUT THIS ONE TOOK OVER THREE HOURS. USED 6 TIMES AND STILL WAS SLOW. ORDERED 3 CS AND USED THE FIRST 6 AND THEY ARE ALL BAD. AND THEY DON'T WANT TO CONTINUE USING THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21160378 ↗
• MalfunctionJan 13, 2025Leak/Splash; Defective Component; Leak/Splash; Defective Component

  MATERIAL # MS3500-15, BATCH # UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THEY ARE EXPERIENCING BREAKING, SEPARATION AND CRACKING OF THE IV TUBING WHEN TAKING THE IV TUBING OUT OF THE PACKAGES. IN ADDITION, WHEN NURSES BEGIN TO PRIME THEIR IV FLUIDS THROUGH THE TUBING, THEY ARE ALSO HAVING ISSUES. ADDITIONALLY, THAT THE NURSES ARE EXPERIENCING LEAKING FROM THE IV TUBING AFTER AN INFUSION HAS BEEN HUNG AND INFUSING FOR A FEW HOURS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NURSES HAVE BEEN EXPERIENCING BREAKING, SEPARATION AND CRACKING OF THE IV TUBING WHEN TAKING THE IV TUBING OUT OF THE PACKAGES. IN ADDITION, WHEN NURSES BEGIN TO PRIME THEIR IV FLUIDS THROUGH THE TUBING, THEY ARE ALSO HAVING ISSUES. ADDITIONALLY, KEITH STATED THAT NURSES ARE EXPERIENCING LEAKING FROM THE IV TUBING AFTER AN INFUSION HAS BEEN HUNG AND INFUSING FOR A FEW HOURS. KEITH STATED THIS MOST COMMONLY IS OCCURRING WITH BD ALARIS PUMP INFUSION SETS THAT ARE USED FOR PRIMARY INFUSIONS IN THE ICU. (REF #(B)(4). NURSES HAVE ALSO EXPERIENCED ISSUES WITH BD SECONDARY SET (REF#(B)(4). NO PATIENT HARM. NO ADDITIONAL DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21139738 ↗
• MalfunctionDec 26, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: IT WAS REPORTED BY CUSTOMER THAT THE DEVICE AT ISSUE APPEARED TO PRIME VERY SLOWLY, ONCE PRIMED THE ANTIBIOTIC BAG WAS ATTACHED AND THE CHAMBER DID BEGIN TO DRIP. HOWEVER, THE ANTIBIOTIC DID NOT INFUSE IN THE TIME ANTICIPATED WHICH IS WHEN I REALIZED THAT THE PRIMARY SET WAS INFUSING ALONG WITH THE SECONDARY SET, WHICH SHOULD NOT HAVE BEEN POSSIBLE. AFTER EXTENSIVE, UNSUCCESSFUL TROUBLESHOOTING OF THE SUSPECTED FAULTY SECONDARY SET I REPLACED IT WITH A NEW ONE WHICH WORKED JUST FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21023093 ↗
• MalfunctionDec 20, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS DAMAGED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM IT WAS REPORTED BY THE CUSTOMER THAT CEFEPIME IN A 100ML BAG WAS SCHEDULED TO RUN OVER 4 HOURS AT 25ML/HR. MEDICATION WAS SCHEDULED TO END AT 1739. RN RETURNED TO THE ROOM AROUND 1500 AND THE BAG OF CEFEPIME WAS EMPTY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20989156 ↗
• MalfunctionDec 9, 2024Material Separation; Material Separation

  MATERIAL#: MS3500-15 BATCH#: UNKNOWN IT WAS REPORTED BY THE CUSTOMER THAT RN SPIKED ANTIBIOTIC WITH SECONDARY TUBING. SECONDARY TUBING BROKE/DETACHED AT THE DRIP CHAMBER SPILLING ANTIBIOTICS ON GROUND. RN REMOVED TUBING FROM ROOM AND OBTAINED A NEW BAG OF ANTIBIOTICS VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20877848 ↗
• MalfunctionOct 27, 2024Partial Blockage; Partial Blockage

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: WE HAVE HAD MULTIPLE ISSUES WITH THIS SECONDARY TUBING NOT INFUSING MEDICATIONS. THIS MEDICATION STARTED DRIPPING IN THE CHAMBER WHEN THE REGISTERED NURSE (RN) STARTED THE MEDICATION, BUT WHEN RN RETURNED IT HAD STOPPED INFUSING, AND THE IV PUMP WAS PULLING FROM PRIMARY FLUID BAG. USUALLY THIS ISSUE IS WITH GLASS VIALS, BUT THIS EVENT WAS WITH A MEDICATION BAG. THERE ARE EXTENSIVE INSTRUCTIONS FOR PRIMING THIS TUBING, AND RN SAYS ALL STEPS WERE FOLLOWED APPROPRIATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20541634 ↗
• MalfunctionOct 12, 2024Leak/Splash; Material Separation; Leak/Splash; Material Separation

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20434949 ↗
• MalfunctionJun 25, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET DISCONNECTED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING: OCCURRENCE: 2 ISSUE: TUBING DISCONNECTED FROM DRIP CHAMBER CAUSING CHEMO SPILL SAMPLE: DISCARDED IMPACTED SAMPLES BUT DOES HAVE REPRESENTATIVE SAMPLES FROM LOT TO RETURN FOR TESTING ADVERSE EVENTS: EXPOSED TO CHEMO COMMENTS ON 10/06/2024 1. DID THE ISSUE HAPPEN DURING PATIENT USE? IF YES, WAS THERE ANY INJURY? IF SO, PLEASE DESCRIBE AND INCLUDE ANY MEDICAL TREATMENT NEEDED AS A RESULT? A. THIS HAPPENED ONCE WHEN RN TOOK THE CHEMO OUT OF THE BAG AND ANOTHER TIME WHEN THEY WERE AT THE WOW DOING A DOUBLE CHECK. B. UNCLEAR IF ANY INJURY BUT RNS AND PATIENT EXPOSED TO CHEMO, LONG TERM AFFECTS UNKNOWN 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. A. UNCLEAR, BUT NOTHING IMMEDIATE 4. DATE OF EVENT: A. ONCE ON 5/31 AND ANOTHER ON 6/1.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19609850 ↗
• MalfunctionJun 25, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET DISCONNECTED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: ISSUE: TUBING DISCONNECTED FROM DRIP CHAMBER CAUSING CHEMO SPILL. SAMPLE: DISCARDED IMPACTED SAMPLES BUT DOES HAVE REPRESENTATIVE SAMPLES FROM LOT TO RETURN FOR TESTING. ADVERSE EVENTS: EXPOSED TO CHEMO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19608728 ↗
• MalfunctionMay 20, 2024Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET SEPARATED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: WE HAVE NOTICED THAT THE SECONDARIES WE RECEIVE FAIL AFTER A FEW DAYS WITH THE PART THAT YOU INSERT TO THE PRIMARY¿S SMARTSITE (TO RUN A SECONDARY) SPLITTING FROM THE COLLAR. ARE YOU RECEIVING ANY REPORTS OF THIS?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19356510 ↗
• MalfunctionApr 24, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING : THE SECOND OCCURRED ON (B)(6)2024 - - CAT# MS3500-15, LOT# UNKNOWN. SAME SITUATION. WHEN THE SECONDARY SET WAS SET UP, IT DID NOT INFUSE, THE PRIMARY LINE WAS DRAINED INSTEAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19170009 ↗
• MalfunctionApr 24, 2024Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET HAD FLOW ISSUES . THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: THE FIRST OCCURRED ON 3/20/24 ¿ CAT# MS3500-15, LOT# (10)23103174- DRUG KEPPRA WAS NOT RUNNING, PULLING FROM PRIMARY BAG.

  Patient problems: Insufficient Information

  MAUDE report 19170002 ↗
• MalfunctionApr 9, 2024Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS BLOCKED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CLINICIANS REPORTED HAVING DIFFICULTY WHEN INFUSING IV TYLENOL AS A SECONDARY INFUSION. CLINICIAN STATED¿ TYLENOL COMES IN A GLASS BOTTLE, IT IS ONE OF THE ONLY MEDICATIONS THAT WE RUN VIA A SECONDARY LINE, WHEN WE HANG IT THE INFUSION STARTS FINE, THEN WHEN WE COME BACK IN THE ROOM TO CHECK IT, THE INFUSION HAS STOPPED¿. BD SECONDARY SET MS3500-15. NO PATIENT HARM. NO ADDITIONAL INFORMATION PROVIDED. CPC REVIEWED SECONDARY SETUP, LUER CONNECTION, AND INFUSING FROM A GLASS BOTTLE WITH CLINICIANS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19075720 ↗
• MalfunctionMar 6, 2024Backflow; Complete Blockage; Backflow; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS OCCLUDED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: 2.7.24- NURSE IN CVC WENT IN AS PUMP WAS BEEPING COMPLETED, SECONDARY LINE WAS CLAMPED, WRITER UNCLAMPED SECONDARY LINE AND REPROGRAMMED PUMP TO INFUSE SECONDARY MEDICATION. 50 MINUTES LATER PUMP BEEPING FOR COMPLETION A SECOND TIME- SECONDARY MEDICATION DID NOT INFUSE, FLUID IN DRIP CHAMBER NOTED. EQUIPMENT/SUPPLIES INVOLVED- BD PUMP INFUSION SET BACK CHECK VALVE REF (B)(4). BD SECONDARY SET (VENTED/NONVENTED) M53500-15. MINI-BAG UNASYN;250 ML NS BAG: LOT #: V23L01K, BRAND: BAXTER;BD SECONDARY SET: LOT #:(10)23103174 BRAND: BD;ALARIS PUMP (#1-206) & CHANNEL (#2-191) ALARIS BRAIN AND CHANNELS ALONG WITH TUBING AND PRODUCT FAILURE FORMS AVAILABLE IN COLLEEN BELL¿S OFFICE. NO CHECKS OF THE ALARIS BRAIN OR CHANNELS BY BIOMED AT THIS TIME AS WE WERE AWAITING BD SITE VISIT FOR NEXT STEPS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18849635 ↗
• MalfunctionFeb 26, 2024Insufficient Flow or Under Infusion; Insufficient Flow or Under Infusion

  UPDATED: MATERIAL GRID TO FLUID BLOCKAGE BASED ON CUSTOMER VERBATIM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18785254 ↗
• MalfunctionFeb 26, 2024Defective Component; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18784663 ↗
• MalfunctionFeb 26, 2024Defective Component; Defective Component

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18775619 ↗
• MalfunctionFeb 13, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS UNDER FUSING THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: CEC ROUNDING ON 4 MAIN AND RN ASKED FOR HELP WITH INFUSING GLASS TYLENOL BOTTLE. RN STATED INFUSION WAS NOT RUNNING CORRECTLY. CEC ASSESSED INFUSION SET UP AND VISUALLY IT WAS CORRECT. CEC ASKED RN HOW INFUSION WAS INITIALLY PRIMED AS A SECONDARY MEDICATION. RN UNSURE AS HE DID NOT HANG OR PRIME MEDICATION. RN OBTAINED NEW SECONDARY INFUSION SET AND CHANGED TUBING. CEC PROVIDED EDUCATION ON PRIMING WITH A GLASS BOTTLE, BY FIRST SETTING GLASS BOTTLE ON COUNTER AND SPIKING BOTTLE, HANGING BOTTLE ON IV POLE AND FILLING THE DRIP CHAMBER 2/3 FULL BEFORE OPENING UP THE VENT CAP. RN RESTARTED INFUSION AND THE SECONDARY TYLENOL INFUSION CONTINUED TO RUN VERY SLOWLY. CEC CONTACTED (B)(6), CC (PREVIOUSLY VISITED SITE WITH CHANGE IN SECONDARY TUBING). (B)(6) STATED THAT TYLENOL NEEDS TO BE VENTED AND TO PROVIDE EDUCATION ON VENTING THE BOTTLE AFTER SPIKING FOR A FEW SECONDS, CLOSING THE VENT CAP AND THEN PROCEEDING TO FILL DRIP CHAMBER, OPEN VENT CAP AND PRIME TUBING. SHE ALSO SUGGESTED TO NOT BACKPRIME GLASS BOTTLE INFUSIONS. THIS EDUCATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18696418 ↗
• MalfunctionFeb 2, 2024

  ELDERLY MALE WITH HISTORY OF MECKEL¿S DIVERTICULITIS AND RECENT ABDOMINAL PAIN. PROCEDURE: INFUSION OF ZOSYN. THE PLASTIC TIP OF THE SECONDARY TUBING WAS FOUND TO BE BROKEN OFF AND INSIDE THE BAG OF ZOSYN. NO KNOWN HARM TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18628929 ↗
• MalfunctionNov 27, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET WAS OCCLUDED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: PATIENT SIDE OCCLUSION ALARMS DUE TO POSITIONAL IV. NO PATIENT HARM REPORTED. NO ADDITIONAL DETAILS PROVIDED. SOMETIMES EXPERIENCE OCCLUSION ALARMS WHEN Y-SITING TWO PRIMARY INFUSIONS TOGETHER RATES COULD BE DIFFERENT OR THE SAME. NO PATIENT HARM REPORTED. NO ADDITIONAL DETAILS PROVIDED. CPC REVIEWED PUMP AND SELECTABLE MODE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18211866 ↗
• MalfunctionNov 21, 2023Infusion or Flow Problem; Infusion or Flow Problem

  IT WAS REPORTED THAT BD ALARIS SECONDARY SET HAD FLOW ISSUES. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE VERBATIM: SHE HAS IT SET UP APPROPRIATELY WITH THE PRIMARY BEING LOWERED, WITH THE AIR PORT(THESE ARE GLASS SECONDARY MEDS) AND CLAMPS OPEN AND THE CONNECTION INSECURE. SHE HAS NOT HAD AN OPPORTUNITY TO TRY IT WITH A NON-GLASS SECONDARY. IT'S THE B BRAUN V1921 SECONDARY IV SET, AND THIS IS THE THIRD TIME IN A COUPLE OF DAYS SHE'S NOTICED THE ISSUE. SHE HAS HAD TO KINK OFF THE PRIMARY TUBING TO GET THE SECONDARY TO RUN, AND ENDED UP BOLUSING A SMALL AMOUNT OF THE IV FLUID INSTEAD OF GIVING THE SECONDARY WITH THE OF THIS ISSUE. NOT A PROBLEM THIS TIME BUT COULD BE IF PRIMARY SET WAS A DIFFERENT FLUID. WE JUST EXPERIENCED THE SAME ISSUE WITH THE NEW TUBING - MS3500-15. THE SECONDARY TUBING WAS SET UP APPROPRIATELY, BUT THE PUMP WAS STILL PULLING FROM THE PRIMARY BAG. IT WAS WITH A GLASS BOTTLE AGAIN AND THE VENT WAS OPEN, ALL CLAMPS WERE OPEN. THE PATIENT WAS BOLUSED A SMALL AMOUNT OF THE PRIMARY FLUID AND DID NOT RECEIVE THE SECONDARY MEDICATION UNTIL THE PROBLEM WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18188695 ↗
• MalfunctionNov 6, 2023Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION WAS PROVIDED. MAT#: MS3500-15, BATCH#: 23069240. IT WAS REPORTED BY CUSTOMER THAT WHERE THE LOCKING INJECTOR AND SECONDARY SET (MS3500-15) CONNECT, THERE ARE DROPLETS PRESENT. CONCERNED IT COULD BE LEAKING. VERBATIM: CUSTOMER CONCERNED THAT WHERE THE LOCKING INJECTOR AND SECONDARY SET (MS3500-15) CONNECT, THERE ARE DROPLETS PRESENT. CONCERNED IT COULD BE LEAKING. WALKED THEM THROUGH PROPER INJECTOR CONNECTION TECHNIQUE. (B)(6) 2023 HERE ARE THE LOT NUMBERS OF THE CURRENT PRODUCTS THAT WE HAVE. THERE WAS NO PATIENT INVOLVEMENT IN THIS INSTANCE. PHASEAL OPTIMA INJECTOR (N40-O), REF: 515056, LOT:2305308, MAN DATE:2023-05-01, EXP:2025-10-31. BD SECONDARY SET, REF: MS3500-15, ALARIS PRODUCTS, EXP: 2026-06-16, LOT: (10) 23069240, (01)10885403222610. THIS COMPLAINT IS BASED ON AN OBSERVATION WHEN PREPARING CHEMO. THE SECONDARY SET IS PRIMED IN AN OPEN FASHION WITH PLAIN FLUID, THEN THE INJECTOR IS ATTACHED TO THE LINE. ONCE CONNECTED, IF YOU TAP THE INJECTOR ON THE COUNTER, DROPLETS WILL RELEASE AT THE CONNECTION SITE. WHERE WOULD THE DROPLETS COME FROM?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18080941 ↗