BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 6883617 · Received September 21, 2017

    Report

    Report Number
    1213809-2017-00136
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    August 30, 2017
    Report Date
    December 19, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    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

    RESULTS - THREE SEALED 3ML PACKAGED INTEGRA SYRINGES WITH NEEDLES FROM BATCHES 4051203 AND 4051206 AND 1 EMPTY PARTIALLY OPENED PACKAGE FROM BATCH 3268036 WERE RECEIVED BY BD (B)(4). ALL SAMPLES WERE FOR P/N 305270 AND WERE EVALUATED. THE THREE SAMPLES FROM NON-COMPLAINT BATCHES 4051203 AND 4051206 ¿ SYRINGES WITH NEEDLES ATTACHED WERE REMOVED FROM PACKAGING TO VERIFY FUNCTION OF PLUNGER RODS. THE PLUNGER RODS WERE EXERCISED AND WERE CONFIRMED TO FUNCTION PROPERLY WITHOUT ANY DEFECTS OBSERVED. THE SINGLE OPEN EMPTY PACKAGE FROM THE COMPLAINT BATCH 3268036 DID NOT CONTAIN A SYRINGE TO BE EVALUATED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER. CONCLUSION - UNCONFIRMED: BD (B)(4) WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE, THE PLUNGER OF THE 3 ML BD INTEGRA¿ RETRACTING SAFETY SYRINGE WITH 25 G X 1 IN. NEEDLE WITH BD¿ TRU-LOK WAS BROKEN OR DAMAGED. PLUNGER WOULDN¿T DEPRESS WITH NEEDLE IN PATIENTS ARM. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661812 25 G X 1 IN. BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE SYRINGE WITH NEEDLE MEG BECTON DICKINSON MEDICAL SYSTEMS 3268036

    Patients

    Seq Age Sex Outcome Treatment
    1 Other