BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 10365719 · Received August 4, 2020

    Report

    Report Number
    1213809-2020-00508
    Event Type
    Malfunction
    Date Received
    August 4, 2020
    Date of Event
    July 14, 2020
    Report Date
    September 1, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052746
    PMA / PMN Number
    K011103
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 EVALUATION?: YES D.10. RETURNED TO MANUFACTURER ON: (B)(6)2020. H.6. INVESTIGATION: EIGHT 100-COUNT SHELF CARTONS FROM BATCH 7177705 (P/N (B)(6)) WERE RECEIVED AND EVALUATED. NO VISUAL DEFECTS WERE OBSERVED. THE RETRACTION MECHANISM WAS ACTIVATED ON ALL 800 SYRINGES WITH NO FUNCTIONAL DEFECTS OBSERVED. BASED ON THE VERBATIM, IT WAS UNCLEAR IF THE DEVICE WAS USED AS INTENDED. INCE THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED, NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE WITH A BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE THE NEEDLE BREAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLES BREAK WHEN PATIENTS HAVE BEEN GIVEN INJECTIONS. NO SERIOUS INJURY HOWEVER BECAUSE THE SYRINGE BROKE WHILST ADMINISTERING AN INJECTION TO THE PATIENT IT WAS IMPOSSIBLE TO ASCERTAIN HOW MUCH MEDICATION HAD BEEN ADMINISTERED TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 7001879, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2017-01-01, MEDICAL DEVICE LOT #: 7177705, MEDICAL DEVICE EXPIRATION DATE: 2022-06-30, DEVICE MANUFACTURE DATE: 2017-06-26." 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 DURING USE WITH A BD INTEGRA¿ 3 ML SYRINGE WITH DETACHABLE NEEDLE THE NEEDLE BREAKS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLES BREAK WHEN PATIENTS HAVE BEEN GIVEN INJECTIONS. NO SERIOUS INJURY HOWEVER BECAUSE THE SYRINGE BROKE WHILST ADMINISTERING AN INJECTION TO THE PATIENT IT WAS IMPOSSIBLE TO ASCERTAIN HOW MUCH MEDICATION HAD BEEN ADMINISTERED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829658 BD INTEGRA 3 ML SYRINGE WITH DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 305274 SEE H.10 30382903052746

    Patients

    Seq Age Sex Outcome Treatment
    1 Other