BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT¿ SYRINGE

    MDR report key: 15839346 · Received November 21, 2022

    Report

    Report Number
    2243072-2022-02017
    Event Type
    Malfunction
    Date Received
    November 21, 2022
    Date of Event
    October 29, 2022
    Report Date
    November 28, 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

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS BAWAL. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(6) HAS BEEN LISTED IN THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2180786 MEDICAL DEVICE EXPIRATION DATE: (B)(6) 2027 DEVICE MANUFACTURE DATE: (B)(6) 2022 MEDICAL DEVICE LOT #: 2180787 MEDICAL DEVICE EXPIRATION DATE: (B)(6) 2027 DEVICE MANUFACTURE DATE: (B)(6) 2022 INITIAL REPORTER ADDR 1: (B)(6). 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 PHOTO WAS RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTO OF A DISCARDIT 2ML WITH 25GX1 NEEDLE FROM LOT # 2180786 & 2180787 REGARDING ITEM # 302438 WITH THE REPORTED ISSUE INCORRECT QTY. & LABELLING ISSUE. THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF MATERIAL NUMBER 302438 AND LOT NUMBER 2180786 & 2180787 FOR INVESTIGATING THE REPORTED DEFECT. THE DHR OF MATERIAL NO. 302438 WITH BATCH NO. 2180786 & 2180787 WAS CHECKED AND THERE WAS NO QUALITY NOTIFICATION FOUND ON THIS LOT NO. FROM ITS PRODUCTION DATE TO ITS DISPATCH ON DATE. THE INVESTIGATION WAS CARRIED OUT ON THE PHOTOGRAPH AND BD BAWAL WAS NOT ABLE TO CONFIRM THE COMPLAINT. THE SCRIBBLED WRITING AND THE RED LABEL ON THE SHIPPER DO NOT BELONG TO BD BAWAL. THE COMPLAINT IS NOT CONFIRMED. THE INVESTIGATION COULD NOT BE DONE FURTHER AS THERE IS NO DETAILED INFORMATION ABOUT THE SHIPPER NUMBER NOR DOES THE RED LABEL OR WRITING ON THE SHIPPER BELONGS TO BD BAWAL UNIT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2,000 BD DISCARDIT¿ SYRINGES EXPERIENCED DAMAGED PACKAGING WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSIGNMENT, WHICH WAS DELIVERED ON (B)(6) AS RECEIVED IN LOOSE QUANTITIES PACKED INSIDE BOXES AND THE BOXES ARE WITHOUT ANY IDENTIFICATION LABELS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2,000 BD DISCARDIT¿ SYRINGES EXPERIENCED DAMAGED PACKAGING WHERE STERILITY WAS COMPROMISED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CONSIGNMENT, WHICH WAS DELIVERED ON OCT 28TH, WAS RECEIVED IN LOOSE QUANTITIES PACKED INSIDE BOXES AND THE BOXES ARE WITHOUT ANY IDENTIFICATION LABELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807795 BD DISCARDIT¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 2180787

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown