BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK

    MDR report key: 13290383 · Received January 19, 2022

    Report

    Report Number
    1213809-2022-00006
    Event Type
    Malfunction
    Date Received
    January 19, 2022
    Date of Event
    December 6, 2021
    Report Date
    January 28, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8092636. MEDICAL DEVICE EXPIRATION DATE: 2023-03-31. DEVICE MANUFACTURE DATE: 2018-05-03.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES, D10: RETURNED TO MANUFACTURER ON: 2022-01-19. H6: INVESTIGATION SUMMARY: ONE PICTURE AND THIRTEEN 10ML LUER-LOK SYRINGES (P/N 309605) WERE RECEIVED AND EVALUATED. FIVE SYRINGES FROM BATCH 8092636 AND EIGHT SAMPLES FROM BATCH 1041906. THE PICTURE AND NONE OF THE THIRTEEN SYRINGES CONTAINED EXCESSIVE SILICONE. ALL SAMPLES RECEIVED WERE ACCEPTABLE PER PRODUCT SPECIFICATION. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK EXCESSIVE SILICONE WAS FOUND IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309605. BATCH NO. 8092636, 1041906. IT WAS REPORTED THAT THERE IS EXCESSIVE SILICONE IN THE SYRINGES. VERBATIM: DURING INCOMING VISUAL INSPECTION OF 10ML SYRINGES, LOT #:8092636 AND 1041906, EACH INSPECTION FAILED DUE TO EXCESSIVE SILICONE IN THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK EXCESSIVE SILICONE WAS FOUND IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309605. BATCH NO. 8092636, 1041906. IT WAS REPORTED THAT THERE IS EXCESSIVE SILICONE IN THE SYRINGES. VERBATIM: DURING INCOMING VISUAL INSPECTION OF 10ML SYRINGES, LOT #:8092636 AND 1041906, EACH INSPECTION FAILED DUE TO EXCESSIVE SILICONE IN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786559 BD SYRINGE 10ML LL TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309605 1041906 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown