BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/BLUNT PLASTIC CANN

    MDR report key: 11803513 · Received May 10, 2021

    Report

    Report Number
    1213809-2021-00305
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 24, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903033461
    PMA / PMN Number
    K974363
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SAMPLES FROM THREE SYRINGE BATCHES, ONE NEEDLE BATCH, AND ONE NON-BD PRODUCT WERE RECEIVED: 164 SEALED PACKAGED SYRINGES FROM BATCH #1008436 (P/N 303346). 91 SEALED PACKAGED SYRINGES FROM BATCH #1043495 (P/N 303346). 74 SEALED PACKAGED SYRINGES FROM BATCH #0353219 (P/N 303346). 294 SEALED PACKAGED AND 1 LOOSE BLUNT PLASTIC CANNULAS FROM BATCH #0252728 (P/N 303345). 1 SEALED PACKAGE FROM NON-BD MONOJECT CANNULA BY COVIDIEN. NONE OF THE CANNULA PRODUCTS WERE MADE AT THIS SYRINGE MANUFACTURING PLANT AND THEREFORE WERE NOT EVALUATED. THE THREE SYRINGE BATCHES WERE SAMPLED FOR 81 TOTAL PIECES (27 FROM EACH) AND HAD THEIR CANNULAS VISUALLY EVALUATED. NO CRACKS, DAMAGE, DEFORMITIES OR OTHER REJECTABLE DEFECTS WERE OBSERVED IN THE SAMPLES. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. IT IS POSSIBLE THE PRODUCT WAS NOT USED PROPERLY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 3ML LL W/BLUNT PLASTIC CANN BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 303346 BATCH NO.: 1008436, 1043495, 0353219 IT WAS REPORTED THAT A PIECE OF THE SYRINGE/CANNULA BREAKS OFF AND IT IS DIFFICULT TO PUSH THE CANNULA THROUGH. PER RESPONSE EMAIL: THESE DEVICES WERE BEING USED ON THE RUBBER VIAL STOPPERS TO PULL UP THE MEDICATION, NOT THE ACTUAL CAP. THEY WERE EXTREMELY HARD TO PUSH IN AND WHEN WE DID GET THEM IN THE VIALS, THERE WERE VISIBLE FRAGMENTS IN VIAL AND PULLED UP INTO THE SYRINGE.

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1008436. MEDICAL DEVICE EXPIRATION DATE: 2025-12-31. DEVICE MANUFACTURE DATE: 2021-01-08. MEDICAL DEVICE LOT #: 1043495. MEDICAL DEVICE EXPIRATION DATE: 2026-01-31. DEVICE MANUFACTURE DATE: 2021-02-12. MEDICAL DEVICE LOT #: 0353219. MEDICAL DEVICE EXPIRATION DATE: 2025-11-30. DEVICE MANUFACTURE DATE: 2020-12-18. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 3ML LL W/BLUNT PLASTIC CANN BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 303346 BATCH NO.: 1008436, 1043495, 0353219. IT WAS REPORTED THAT A PIECE OF THE SYRINGE/CANNULA BREAKS OFF AND IT IS DIFFICULT TO PUSH THE CANNULA THROUGH. PER RESPONSE EMAIL: THESE DEVICES WERE BEING USED ON THE RUBBER VIAL STOPPERS TO PULL UP THE MEDICATION, NOT THE ACTUAL CAP. THEY WERE EXTREMELY HARD TO PUSH IN AND WHEN WE DID GET THEM IN THE VIALS, THERE WERE VISIBLE FRAGMENTS IN VIAL AND PULLED UP INTO THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695599 SYRINGE 3ML LL W/BLUNT PLASTIC CANN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS SEE H.10 00382903033461

    Patients

    Seq Age Sex Outcome Treatment
    1