BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ II - 2-PIECE SYRINGE

    MDR report key: 16792325 · Received April 21, 2023

    Report

    Report Number
    2243072-2023-00656
    Event Type
    Malfunction
    Date Received
    April 21, 2023
    Date of Event
    March 31, 2023
    Report Date
    June 1, 2023
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURING LOCATION FOR THIS PRODUCT IS BAWAL, INDIA. THIS SITE IS NOT REGISTERED WITH THE FDA. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 18-MAY-2023. H6: INVESTIGATION SUMMARY: SAMPLES AND PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PICTURES AND INSPECT THE RETURNED SAMPLES FOR THE REPORTED ISSUE OF SPECIAL DEFECTS FOR MATERIAL NUMBER 301866 AND LOT NUMBERS 1212268, 1217218, 1345889, 2010890, 2038586, 2061252. THE INVESTIGATING TEAM HAS ALSO USED RETENTION SAMPLES FOR INVESTIGATION. THE DEVICE HISTORY REVIEW OF MATERIAL NUMBER 301866 WITH LOT NUMBERS 1212268, 1217218, 1345889, 2010890, 2038586, 2061252 WAS CHECKED AND THERE WAS NO QUALITY NOTIFICATION FOUND ON THESE LOTS FROM ITS PRODUCTION DATE TO ITS DISPATCH ON DATE. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR SPECIAL DEFECTS IN SYRINGE AND NO DEFECT WAS FOUND IN THE RETENTION SAMPLES. THE INVESTIGATION WAS ALSO CARRIED OUT ON THE PHOTOGRAPH & SAMPLES AS WELL. THE PHOTOGRAPH & SAMPLES CONFIRMS THE REPORTED DEFECT IN THE SYRINGE. THE ROOT CAUSES WERE RELATED TO PREVENTIVE MAINTENANCE AND TECHNOLOGY. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD DISCARDIT¿ II - 2-PIECE SYRINGE EXPERIENCED MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A TOTAL OF (B)(4) UNITS HAS BEEN IMPACTED DUE TO THESE COMPLAINTS. [06 APRIL 2023] ¿ RCC REVIEWED THE SUPPORTING EVIDENCE AND FOUND THERE ARE TOTAL OF (B)(4) BATCHES AFFECTED WITH EACH BATCH CONTRIBUTE TO DIFFERENT TYPE OF DEFECTS SUCH AS BLACK SPOT, BLISTER LEAKAGE, NO NEEDLE. DOUBLE NEEDLE. MARKING DEFECTS, FOREIGN PARTICLES, DAMAGE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD DISCARDIT¿ II - 2-PIECE SYRINGE EXPERIENCED MIX OF PRODUCT TYPES IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A TOTAL OF (B)(4) UNITS HAS BEEN IMPACTED DUE TO THESE COMPLAINTS. [06 APRIL 2023] ¿ RCC REVIEWED THE SUPPORTING EVIDENCE AND FOUND THERE ARE TOTAL OF 7 BATCHES AFFECTED WITH EACH BATCH CONTRIBUTE TO DIFFERENT TYPE OF DEFECTS SUCH AS BLACK SPOT, BLISTER LEAKAGE, NO NEEDLE. DOUBLE NEEDLE. MARKING DEFECTS, FOREIGN PARTICLES, DAMAGE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446649 BD DISCARDIT¿ II - 2-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 1212268

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown