BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 5/8 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 6904291 · Received September 29, 2017

    Report

    Report Number
    1213809-2017-00155
    Event Type
    Malfunction
    Date Received
    September 29, 2017
    Date of Event
    September 6, 2017
    Report Date
    December 27, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: DHR REVIEW FOR BATCH 6201979 (P/N 305269): MANUFACTURING DATES: 08/12/2016 TO 08/14/2016. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 6201979 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. NO SAMPLES WERE RECEIVED WITH A COMPLAINT LABEL #(B)(4). HOWEVER, PER CUSTOMERS EMAIL THE SAMPLES ARE LINKED TO PR# (B)(4). SAMPLES FOR (B)(4) DID NOT HAVE IDENTIFIABLE INFORMATION AND WERE RECEIVED LOOSE IN SHARPS CONTAINER. SYRINGE 1 - SYRINGE IS ACTIVATED BUT PLUNGER ROD IS NOT IN FULL / BOTTOM POSITION. THIS IS EVIDENCE OF ACTIVATION PRIOR TO COMPLETION OF SYRINGE USE. NO LIQUID OR CRACKS WERE OBSERVED ON THE SYRINGE EXTERIOR. THE PREMATURE ACTIVATION CAN HAPPEN IF THE STOPPER ENCOUNTERED SUFFICIENT RESISTANCE DURING USE. THE NEEDLE WAS FOUND NOT RETRACTED  RETRACTION FAILURE. SYRINGE 2 - THE SYRINGE APPEARED USED. THE EVALUATION WAS PERFORMED VISUALLY ONLY, FUNCTION AND LEAKAGE WAS NOT TESTED DUE TO THE SYRINGE CONTAINING AN UNIDENTIFIED LIQUID. DURING THE VISUAL EVALUATION A PIECE OF TAPE WAS OBSERVED ATTACHED TO THE BARREL EXTERIOR AND WHAT APPEARS TO BE ADHESIVE IS ON THE BARREL EXTERIOR NEAR THE BARREL THREADS. NO LIQUID OR CRACKS WERE OBSERVED ON THE SYRINGE EXTERIOR. THE SYRINGE WAS NOT ACTIVATED WITH STOPPER STILL INTACT AND THE NEEDLE WAS NOT YET RETRACTED. THE DEFECTS OBSERVED WERE ADDRESSED IN PR# (B)(4). SAMPLES DID NOT MATCH DESCRIPTION BY CUSTOMER. BASED ON THE SAMPLE EVALUATION, UNCONFIRMED: BD (B)(4) WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. CAPA IS NOT REQUIRED AS NO DEFECTS WERE CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 25 G X 5/8 IN. BD INTEGRA" 3 ML SYRINGE WITH DETACHABLE NEEDLE WAS LEAKING, AND WHEN LOCKING THE NEEDLE, THE NEEDLE DETACHED FROM THE HUB. NO REPORTED MEDICAL INTERVENTION OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684182 25 G X 5/8 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE SYRINGE WITH NEEDLE FMF BECTON DICKINSON MEDICAL SYSTEMS 6201979

    Patients

    Seq Age Sex Outcome Treatment
    1 Other