BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 21703992 · Received March 26, 2025

    Report

    Report Number
    1911916-2025-00239
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    March 20, 2025
    Report Date
    April 17, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028321
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED THERE ARE INDENTATIONS ON THE PACKAGING. TO AID IN THE INVESTIGATION, TWO SAMPLES IN SEALED PACKAGING BLISTERS AND ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. ONE SAMPLE IS FROM LOT 4354258, AND ONE SAMPLE IS FROM LOT 5003597. A VISUAL INSPECTION WAS PERFORMED WITH 30X MAGNIFICATION. THE PACKAGING BLISTER BOTTOM WEBS HAVE TWO ROWS OF SMALL BUMPS THAT ARE 3/8" FROM EACH OTHER. ONE PACKAGING BLISTER BOTTOM WEB HAS THE NUMBER '8' AND THE OTHER PACKAGING BLISTER BOTTOM WEB HAS THE NUMBER '5.' THE DOTS ARE NOT PERFORATIONS, AND THE NUMBERS ARE NOT DEFECTS. THE PHOTO PROVIDED SHOWS THE SAMPLE RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOTS 4354258 AND 5003597. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE PRODUCTION LINE, INCLUDING PACKAGING, WAS VALIDATED AND CONFIRMED THE PRODUCTS ARE STERILE. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOMS REPORTED BY THE CUSTOMER ARE CONFIRMED BUT ARE NOT DEFECTS.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    MATERIAL#: 302832 BATCH#: 4354258 AND 5003597. VERBATIM: SOME CLINICAL STAFF HAVE RAISED CONCERNS REGARDING SOME INDENTATIONS IN THE PACKAGING OF BD STERILE 30CC SYRINGE. REF AND LOT #S PROVIDED IN EMAIL HEADER. PLEASE VIEW THE PICTURE BELOW. WE HAVE ENCOUNTERED AT LEAST 2 IMPACTED LOTS. THERE APPEARS TO BE A SERIES OF DOTS AND A NUMBER THAT CREATE INDENTATIONS ON THE PACKAGING AND CLINICAL STAFF ARE CONCERNED THAT THIS COULD POTENTIALLY COMPROMISE THE INTEGRITY OF THE PACKAGING. HAVE YOU HAD ANY OTHER SITES RAISE CONCERNS? ARE YOU ABLE TO PROVIDE ANY INFORMATION?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2432803 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON 5003597 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown