BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 5154862 · Received October 15, 2015

    Report

    Report Number
    8041187-2015-00013
    Event Type
    Injury
    Date Received
    October 15, 2015
    Date of Event
    September 21, 2015
    Report Date
    December 1, 2015
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY THE MANUFACTURER IS USED. THE CLINICIAN USED THE FOLLOWING TWO DEVICES BUT IT IS UNKNOWN WHICH IS THE SUSPECT DEVICE FOR THIS INCIDENT. 1) MEDICAL DEVICE BRAND NAME: BD SLIP TIP 5ML SYRINGE, CATALOG # 302130, LOT # 5110125, DEVICE MANUFACTURE DATE: 4/20/2015, DEVICE EXPIRATION DATE: 4/30/2020. 2) MEDICAL DEVICE BRAND NAME: BD SLIP TIP 10ML SYRINGE, CATALOG # 302143, LOT # 5110136, DEVICE MANUFACTURE DATE: 4/20/2015, DEVICE EXPIRATION DATE:04/30/2020. THIS DEVICE DOES NOT HAVE A 510(K)#. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. A SAMPLE IS AVAILABLE FOR INVESTIGATION BUT NOT YET RECEIVED.

    Additional Manufacturer Narrative · 1

    RESULT - TWO UNUSED SAMPLES WERE RETURNED FOR CATALOG 302130, LOT 5110125. THREE UNUSED SAMPLES WERE RETURNED FOR CATALOG 302143, LOT 5110136. FROM THE RETURNED SAMPLES, THE BREAKOUT AND SUSTAINING FORCE IS WITHIN THE PRODUCT SPECIFICATIONS. NO DEFECT IS OBSERVED ON THE RETURNED SAMPLES.CONCLUSION - AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    NO SAMPLE HAS BEEN RECEIVED TO DATE. IF A SAMPLE IS RETURNED, AN EVALUATION WILL BE PERFORMED AND AN ADDITIONAL SUPPLEMENTAL REPORT WILL BE FILED. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR THE LOT REPORTED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO ABNORMALITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBERS 5110125 AND 5110136.CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD SYRINGE, THE CLINICIAN EXPERIENCED DIFFICULTY MOVING THE PLUNGER. AS A RESULT, THE CLINICIAN EXPERIENCED AN INJURY AND INFLAMMATION TO HER HAND. SHE WENT TO THE DOCTOR AND HAD THREE UNSPECIFIED MEDICATION INJECTIONS TO HER HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682182 UNKNOWN SYRINGE FMF BECTON DICKINSON MEDICAL (SINGAPORE) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention