BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL AMBER

    MDR report key: 11285710 · Received February 5, 2021

    Report

    Report Number
    3003152976-2021-00068
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 13, 2021
    Report Date
    April 6, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-02-08. H6: INVESTIGATION SUMMARY: TWENTY THREE SEALED SAMPLES WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, NO ISSUES RELATED TO THE SCALE WERE OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1604229P, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. DURING THE BARREL PRINTING PROCESS, OPERATORS PERIODICALLY VERIFY THE VOLUME ACCURACY WITH A PASS/NON PASS GAUGE. FIVE OF THE RETURNED SAMPLES WERE EVALUATED USING THE SAME METHOD AND WERE FOUND TO BE WITHIN REQUIRED TOLERANCE. SCALE PRECISION AND DEAD SPACE IS ALSO INSPECTED DURING MANUFACTURING AND PRODUCT WAS FOUND TO BE WITHIN SPECIFICATION. ADDITIONAL TESTING WAS CONDUCTED ON THE SAMPLES IN RELATION TO THE PLUNGER MOVEMENT TO VERIFY IF THERE MAY HAVE BEEN ANY IMPACT RELATED TO THE REPORTED FAILURE. SILICONE CONTENT AND FORCE TESTING WAS PERFORMED, IN ALL CASES THE PRODUCT MET REQUIRED SPECIFICATION AND NO ISSUES WERE OBSERVED. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 50ML LL AMBER WAS DISPLAYING THE WRONG INFUSION TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOLLOWING THE PUMP ISSUE, I TOOK THE TIME TO CARRY OUT A TEST WITH 3 X 50 ML BD PLASTIPAK SYRINGES. I HAVE PROGRAMMED AN INFUSION OF 24H: 24CC PREPARED IN THE SYRINGE AT A SPEED OF 1CC/H THE REMAINING TIME TO BE DISPLAYED SHOULD BE AROUND 24 HOURS. 2 BATCHES WERE FOUND TO BE FAULTY AND ONE BATCH SEEMS TO BE WORKING WELL. SYRINGE BD 50 OPAQUE BATCH: 1604229P : DISPLAYS INFUSION TIME OF 23 H 15 MIN INSTEAD OF 24 HOURS. SYRINGE BD 50 TRANSPARENT BATCH: 2003283 : DISPLAYS A DURATION OF INFUSION FOR 23 H 15 MIN INSTEAD OF 24 HOURS. SYRINGE BD 50 TRANSPARENT BATCH: 1910716: DISPLAYS A DURATION OF INFUSION FOR 23 H 53 MIN, WHICH IS WELL WITHIN THE INFUSION RATE. THIS IMPLIES THAT THE 2 DEFECTIVE ONES DO NOT ALLOW TO RESPECT THE POSOLOGY OF MEDICAL PRESCRIPTIONS. I KEPT THE SYRINGES I USED TO DO THE TESTS. TESTS THAT I CARRIED OUT ON 2 DIFFERENT PES WITH THE SAME RESULTS.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 50 ML LL AMBER WAS DISPLAYING THE WRONG INFUSION TIME. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOLLOWING THE PUMP ISSUE, I TOOK THE TIME TO CARRY OUT A TEST WITH 3 X 50 ML BD PLASTIPAK SYRINGES. I HAVE PROGRAMMED AN INFUSION OF 24H: 24CC PREPARED IN THE SYRINGE AT A SPEED OF 1CC/H THE REMAINING TIME TO BE DISPLAYED SHOULD BE AROUND 24 HOURS. 2 BATCHES WERE FOUND TO BE FAULTY AND ONE BATCH SEEMS TO BE WORKING WELL. SYRINGE BD 50 OPAQUE BATCH: 1604229P DISPLAYS INFUSION TIME OF 23 H 15 MIN INSTEAD OF 24 HOURS. SYRINGE BD 50 TRANSPARENT BATCH: 2003283 DISPLAYS A DURATION OF INFUSION FOR 23 H 15 MIN INSTEAD OF 24 HOURS. SYRINGE BD 50 TRANSPARENT BATCH: 1910716 DISPLAYS A DURATION OF INFUSION FOR 23 H 53 MIN, WHICH IS WELL WITHIN THE INFUSION RATE. THIS IMPLIES THAT THE 2 DEFECTIVE ONES DO NOT ALLOW TO RESPECT THE POSOLOGY OF MEDICAL PRESCRIPTIONS. I KEPT THE SYRINGES I USED TO DO THE TESTS. TESTS THAT I CARRIED OUT ON 2 DIFFERENT PES WITH THE SAME RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184130 SYRINGE 50ML LL AMBER SYRINGE FMF BECTON DICKINSON, S.A. 1604229P

    Patients

    Seq Age Sex Outcome Treatment
    1