BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ SYRINGE

    MDR report key: 15789524 · Received November 14, 2022

    Report

    Report Number
    2243072-2022-01939
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    July 11, 2022
    Report Date
    November 14, 2022
    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 (B)(4) HAS BEEN LISTED IN SECTIONS THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INITIAL REPORTER PHONE#: UNKNOWN. INITIAL REPORTER E-MAIL: UNKNOWN. 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

    H6. INVESTIGATION SUMMARY: THE TEN PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO OF A DISCARDIT 2ML WITH 25GX1 NEEDLE FROM LOT #2150646 REGARDING ITEM # 302438 WITH THE REPORTED COMPLAINT OF MULTIPLE DEFECTS (BLACK SPOT, FOREIGN PARTICLES, AND HAIR PARTICLES) IN THE SYRINGE. THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF LOT #2150646 REGARDING ITEM # 302438 FOR INVESTIGATING THE REPORTED DEFECT. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR DEFECTS NO DEFECT IN SYRINGE WAS FOUND IN THE RETENTION SAMPLES. THE INVESTIGATION WAS ALSO CARRIED OUT ON THE PHOTOGRAPH AS WELL. THE PHOTOGRAPH CONFIRMS THE REPORTED DEFECT IN THE SYRINGE. THE DHR OF MATERIAL NO. 302438 WITH BATCH NO. 2150646 WAS CHECKED AND THERE WAS NO QUALITY NOTIFICATION FOUND ON THIS LOT NO.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 111 BD DISCARDIT¿ SYRINGES' PACKAGING UNITS HAD POOR PERFORATION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "(B)(4) UNITS HAVING DEFECTS LIKE BLACK SPOT, FOREIGN PARTICLES, MARKING DEFECTS.''

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 111 BD DISCARD IT¿ SYRINGES' PACKAGING UNITS HAD POOR PERFORATION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 4TH OF 6 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "15750 UNITS HAVING DEFECTS LIKE BLACK SPOT, FOREIGN PARTICLES, MARKING DEFECTS..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350334 BD DISCARDIT¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 2150646

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown