BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL BNS

    MDR report key: 11125139 · Received January 6, 2021

    Report

    Report Number
    1213809-2020-00951
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 9, 2020
    Report Date
    February 19, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 2/5/2021. H.6. INVESTIGATION: 430 LOOSE 10ML SYRINGES WERE RECEIVED AND EVALUATED. FOUR SYRINGES HAD NO DEFECTS PRESENT. 426 OF THE SYRINGES WERE OBSERVED TO HAVE SIMILAR DAMAGE THAT MAINLY CONSISTED OF A LARGE SCUFF MARK WITH PLASTIC FIBERS PROTRUDING OUTWARDS AND AN OVAL SHAPED BARREL DEFORMATION. THE SCUFF MARK EXTENDED FROM THE LOGO AREA TO THE 7ML MARKING WITH SOME OF THE SYRINGES ALSO HAVING SMALL CRACKS IN THE BARREL AND A DAMAGED PLUNGER ROD RIB IN THE CONSISTENT LOCATION. 192 OF THE SYRINGES HAD THE SCUFF IN THE PRINT AREA WITH AT LEAST ONE PRINTED ITEM MISSING AT LEAST 50%. THE DAMAGE AND MISSING PRINT WERE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARRELS AND MISSING PRINT DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. IT IS POSSIBLE A PART WAS TEMPORARILY CAUGHT IN THE TOOLING RESULTING IN THE DAMAGE OBSERVED. 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 10ML LL BNS PLUNGER WAS DAMAGED AND THERE ARE SCALE MARKING ISSUES. THIS OCCURRED ON 427 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301029 BATCH NO.: 9273358. IT WAS REPORTED THAT THE PLUNGER IS DAMAGED AND SCALE MARKINGS ARE ERASED OR IRREGULAR. PER FORM: PLUNGER IS DAMAGED AND IN MANY CASES, GRADUATIONS ARE ERASED OR IRREGULAR.

    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 10ML LL BNS PLUNGER WAS DAMAGED AND THERE ARE SCALE MARKING ISSUES. THIS OCCURRED ON 427 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 301029, BATCH NO.: 9273358. IT WAS REPORTED THAT THE PLUNGER IS DAMAGED AND SCALE MARKINGS ARE ERASED OR IRREGULAR. PER FORM: PLUNGER IS DAMAGED AND IN MANY CASES, GRADUATIONS ARE ERASED OR IRREGULAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23050 SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9273358

    Patients

    Seq Age Sex Outcome Treatment
    1