BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTEGRA SYRINGE W/ DETACHABLE NEEDLE

    MDR report key: 9416094 · Received December 5, 2019

    Report

    Report Number
    1213809-2019-01219
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    November 19, 2019
    Report Date
    December 18, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    30382903052708
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED FOR EVALUATION. POTENTIAL ROOT CAUSE FOR THE RETRACTION FAILURE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THE REPORTED DEFECT WAS FOUND DURING THE MANUFACTURING OF THIS BATCH AND A RE-QUALIFICATION WAS PERFORMED. IT IS POSSIBLE A FEW DEFECTIVE SAMPLES WERE ABLE TO ESCAPE DETECTION. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 8002918 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTEGRA¿ SYRINGE W/ DETACHABLE NEEDLE WAS UNABLE TO RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305270 BATCH NO. POSSIBLE 8002918. IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT AND UNABLE TO RETRACT AFTER WITHDRAWN FROM PATIENT. RETRACTING COMPONENT OF SYRINGE ACTIVATED WHEN INJECTING A PATIENT, APPROXIMATELY 0.2 MLS REMAINED IN THE SYRINGE. NEEDLE DID NOT RETRACT AND UNABLE TO RETRACT AFTER WITHDRAWN FROM PATIENT.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD INTEGRA¿ SYRINGE W/ DETACHABLE NEEDLE WAS UNABLE TO RETRACT DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305270 BATCH NO. POSSIBLE 8002918. IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT AND UNABLE TO RETRACT AFTER WITHDRAWN FROM PATIENT. RETRACTING COMPONENT OF SYRINGE ACTIVATED WHEN INJECTING A PATIENT, APPROXIMATELY 0.2 MLS REMAINED IN THE SYRINGE. NEEDLE DID NOT RETRACT AND UNABLE TO RETRACT AFTER WITHDRAWN FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215366 BD INTEGRA SYRINGE W/ DETACHABLE NEEDLE PISTON SYRINGE MEG BECTON DICKINSON MEDICAL SYSTEMS 305270 UNKNOWN 30382903052708

    Patients

    Seq Age Sex Outcome Treatment
    1 Other