BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML ST BULK CONVENIENCE PAK

    MDR report key: 18981950 · Received March 26, 2024

    Report

    Report Number
    1920898-2024-00097
    Event Type
    Malfunction
    Date Received
    March 26, 2024
    Date of Event
    March 6, 2024
    Report Date
    March 11, 2024
    Manufacturer
    BD MEDICAL - DIABETES CARE
    Product Code
    FMF
    UDI-DI
    30382903097013
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.4. OTHER LOT NUMBER INCLUDES 3212533 AND OTHER EXPIRATION DATE INCLUDES 2027-10-31. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2023-08-21.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML ST BULK CONVENIENCE PAK LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT WE ARE CURRENTLY EXPERIENCING MULTIPLE LEAKING SYRINGES WITH TWO LOT NUMBERS. VERBATIM: WE HAVE RECEIVED THE BELOW PRODUCT PROBLEM REPORT. STEVENS REF#(B)(4) HAS BEEN ASSIGNED TO THIS ISSUE. UPON COMPLETION, PLEASE PROVIDE A QUALITY INVESTIGATION LETTER DETAILING YOUR FINDINGS. PLEASE ADVISE ON NEXT STEPS FOR QUALITY INVESTIGATION AND CUSTOMER RESOLUTION: ________________________________________ PRODUCT PROBLEM REPORT PRODUCT INFORMATION PRODUCT CODE: 309701 PRODUCT DESCRIPTION: SYRINGE HYPO 1CC L/S CONV PACK && BULK STER BX/25 LOT/SERIAL #: (B)(6). EXPIRY DATE: 2027-10-31 PROBLEM INFORMATION WE ARE CURRENTLY EXPERIENCING MULTIPLE LEAKING SYRINGES WITH TWO LOT NUMBERS. OCCURRENCES: RECURRING REPORTER INFORMATION REPORTER NAME: XXXX REPORTER POSITION/DEPARTMENT: MATERIAL MGMT REPORTER PHONE: XXXX REPORTER EMAIL: (B)(6). SITE INFORMATION XXXXX SAMPLE INFORMATION INCIDENT SAMPLES: YES -PENDING QTY REPRESENTATIVE SAMPLES: YES- PENDING QTY NO ADVERSE EVENT REPORTED ------------------------------------- PLEASE FIND ATTACHED PRODUCT COMPLAINT(S) FOR YOUR INVESTIGATIONAL ACTION FOR RESOLUTION, AWARENESS AND OR REPLACEMENT: SCMSS (INTERNAL) COMPLAINT #: (B)(4). PRODUCT NAME: SYRINGE, IV STERILE 1 ML PRODUCT CODE & LOT # (IF AVAILABLE): 309701 LOTS #(S): 3212533/2321369 SITE: (B)(6). MATERIALS MANAGEMENT CONTACT AT THE SITE: XXXXX VENDOR/INDUSTRY PARTNER: 1. RESPOND TO EVERYONE INCLUDED IN THIS EMAIL-ALL COMMUNICATION UNTIL RESOLUTION OF INVESTIGATION. 2. INCLUDE SCMSS (INTERNAL) COMPLAINT NUMBER FOR REFERENCE IN ALL COMMUNICATION 3. CONTACT SITE MAT MAN (CC¿D HERE) DIRECTLY FOR ANY QUESTIONS CONCERNING COMPLAINT DETAILS AND/OR RETURNING OF SAMPLES FOR INVESTIGATION. IF QUESTIONS ARE CLINICAL IN NATURE- MAT MAN TO CONTACT CONFIDENTIAL-IDENTIFIED PLAINTIFF FOR REQUESTED ANSWERS AND FORWARD TO VENDOR. * MATERIEL MANAGEMENT: PLEASE KEEP ALL DEFECTIVE PRODUCT(S). PLEASE CONSULT WITH VENDOR TO VALIDATE IF THEY ACCEPT CONTAMINATED PRODUCTS AND/OR IF THEY REQUIRE THE RETURN IN A HAZARDOUS BAG. IF THE CONTAMINATE IS AVAILABLE ONLY [E.G. ITEM DISCARDED], PLEASE SEND A PHOTO OF THE CONTAMINATE. PLEASE FOLLOW SITE POLICY RELATED TO SAFE HANDLING OF CONTAMINATED PRODUCTS/GOODS. **IF PRODUCT WAS INVOLVED IN A CRITICAL INCIDENT, PLEASE HAVE MANAGER CONTACT LEGAL FOR ASSISTANCE WITH ANY INQUIRIES FROM VENDORS/INDUSTRY PARTNERS CONCERNING EITHER THE PATIENT AND OR DEFECTIVE PRODUCT IN QUESTION. **

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441466 BD SYRINGE 1ML ST BULK CONVENIENCE PAK PISTON SYRINGE FMF BD MEDICAL - DIABETES CARE 2321369 30382903097013

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown