BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE BOIN TUBE 10ML 21G 1-1/4IN

    MDR report key: 10668533 · Received October 13, 2020

    Report

    Report Number
    2243072-2020-01643
    Event Type
    Malfunction
    Date Received
    October 13, 2020
    Date of Event
    September 2, 2020
    Report Date
    November 20, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-10-12. H6: INVESTIGATION SUMMARY: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 1002182. VISUAL INSPECTION: SBDM CONDUCT VISUAL INSPECTION OF THE RECEIVED COMPLAINT SAMPLE AND FOUND FAULTY GASKET IN THE SAMPLE. HOUSE SAMPLE INSPECTION: SBDM INSPECTED A TOTAL 30 HOUSE SAMPLES FROM LOT NO. 1001092, 1002182 & 1002192, THERE WAS NO DEFECTIVE PRODUCT FOUND IN THEM. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD, NO ABNORMALITY OBSERVED. CUSTOMER COMPLAINT RECORD REVIEW: SBDM REVIEWED THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE IS SIMILAR ISSUE OF THE SIMILAR PRODUCT FROM OTHER CUSTOMER. ROOT CAUSE: THE LIKELY CAUSE IS WHEN A PLUNGER AND A GASKET(STOPPER) WERE ASSEMBLED, A DEFECT PRODUCT MAYBE GENERATED DUE TO IMPRECISE ASSEMBLY AND LINE WORKERS MAY BE MISSED THE DEFECT SAMPLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE BOIN TUBE 10ML 21G 1-1/4IN STOPPER WAS FOUND DEFECTIVE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DEFECTIVE GASKET FOUND FAULTY GASKET AFTER OPENING PACKAGE FOR USE".

    Additional Manufacturer Narrative · 1

    (B)(4) MANUFACTURER: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4) . THIS SITE IS AN (B)(4) MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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 THE SYRINGE BOIN TUBE 10ML 21G 1-1/4IN STOPPER WAS FOUND DEFECTIVE BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DEFECTIVE GASKET FOUND FAULTY GASKET AFTER OPENING PACKAGE FOR USE"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1134219 SYRINGE BOIN TUBE 10ML 21G 1-1/4IN SYRINGE FMF BECTON DICKINSON 1002182

    Patients

    Seq Age Sex Outcome Treatment
    1 Other