BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 10418228 · Received August 17, 2020

    Report

    Report Number
    1213809-2020-00538
    Event Type
    Malfunction
    Date Received
    August 17, 2020
    Date of Event
    July 27, 2020
    Report Date
    October 1, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052692
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    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: 2020-09-18. H.6. INVESTIGATION SUMMARY: ONE POTENTIALLY USED INTEGRA SYRINGE, WRAPPED IN AN OPENED BLISTER PACKAGE FROM BATCH #9142818 (P/N 305269), WAS RECEIVED. THE SAMPLE WAS VISUALLY EVALUATED. THE STOPPER WAS OBSERVED TO BE AT THE BOTTOM OUT POSITION WHILE THE PLUNGER THUMB REST WAS ABOVE THE BARREL SHROUD. THE NEEDLE WAS FOUND TO NOT HAVE BEEN RETRACTED YET. NO VISUAL DEFECTS WERE OBSERVED. THE HUB WAS FOUND TO BE LOOSELY ATTACHED TO THE BARREL ¿ IT WAS LOOSE BY A FULL ONE THIRD OF A TURN. THE PLUNGER WAS PRESSED ON TO ACTIVATE RETRACTION MECHANISM. THE TWO CLICKS WERE FELT AND HEARD AND THE CANNULA SUCCESSFULLY RETRACTED AS DESIGNED WITH NO ISSUES OBSERVED. NO DEFECTS WERE FOUND IN THE RETURNED SAMPLE. FURTHERMORE, 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 THE BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE EXPERIENCED THE NEEDLE AND SYRINGE SEPARATING/SPINNING OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE NEEDLE HUB CAME AWAY FROM SYRINGE DURING INJECTION WITH B12. NEEDLE HUB STAYED IN HER LEG THAT SHE WAS ABLE TO REMOVE ON HER OWN. COMPLETED INJECTION WITH THIS SYRINGE. SOME MEDICATION CAME OUT ON HER LEG. LOT #: 9142818. CATALOG#: 305269. DATE OF EVENT: UNKNOWN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE EXPERIENCED THE NEEDLE AND SYRINGE SEPARATING/SPINNING OUT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER REPORTED FOUND 1 SYRINGE NEEDLE HUB CAME AWAY FROM SYRINGE DURING INJECTION WITH B12. NEEDLE HUB STAYED IN HER LEG THAT SHE WAS ABLE TO REMOVE ON HER OWN. COMPLETED INJECTION WITH THIS SYRINGE. SOME MEDICATION CAME OUT ON HER LEG LOT #: 9142818 CATALOG#: 305269 DATE OF EVENT: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876547 BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 305269 9142818 30382903052692

    Patients

    Seq Age Sex Outcome Treatment
    1 Other