BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYRINGE 20ML LL S/C 50

    MDR report key: 11159521 · Received January 13, 2021

    Report

    Report Number
    9614033-2021-00005
    Event Type
    Injury
    Date Received
    January 13, 2021
    Date of Event
    December 4, 2020
    Report Date
    February 8, 2021
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: IT WAS RECEIVED 3 PHOTOGRAPHS IN WHICH IT IS POSSIBLE TO OBSERVE IN EACH ONE OF THIS A SYRINGE WITH THE DAMAGE BARREL, THE PHOTOGRAPHS SHOWS THE BLISTER PAPER TOO IN WHICH ITS POSSIBLE TO OBSERVE THE CODE 303310 AND THE BATCHES 0136387 AND 0098741 THE SAME THAT THE CUSTOMER REPORTED. 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. THE DAMAGE TO THE SYRINGE CAN BE GENERATED BY EXCESS SYRINGES ASSEMBLED IN THE HOPPER, AS THERE IS ACCUMULATION OF SYRINGE ASSEMBLED IN THE ELEVATOR, THIS GENERATED OBSTRUCTION AND DAMAGE TO THE SYRINGE ASSEMBLED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYRINGE 20ML LL S/C 50 WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 303310 BATCH NO: 0136387, 0098741.   IT WAS REPORTED THAT 3 SYRINGES CRACKING DOWN THE RIGHT SIDE OF THE SYRINGE.   VERBATIM: REPORT OF 3 SYRINGES CRACKING DOWN THE RIGHT SIDE OF THE SYRINGE. SPRAYED TECH IN THE FACE W/ VENOFOR(?), HE SOUGHT MEDICAL ATTN, INITIALS JMM, WEEK OF (B)(6) SHE HAS THE SYRINGES AVAILABLE TO RETURN.

    Additional Manufacturer Narrative · 1

    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 20ML LL S/C 50 WAS CRACKED AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: (B)(4). BATCH NO: 0136387, 0098741.   IT WAS REPORTED THAT 3 SYRINGES CRACKING DOWN THE RIGHT SIDE OF THE SYRINGE.   VERBATIM: REPORT OF 3 SYRINGES CRACKING DOWN THE RIGHT SIDE OF THE SYRINGE. SPRAYED TECH IN THE FACE W/ VENOFOR(?), HE SOUGHT MEDICAL ATTN, INITIALS JMM, WEEK OF DEC 4TH SHE HAS THE SYRINGES AVAILABLE TO RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61176 SYRINGE 20ML LL S/C 50 PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 0098741

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention