BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL W/NDL 21X1 RB

    MDR report key: 10880891 · Received November 21, 2020

    Report

    Report Number
    1213809-2020-00821
    Event Type
    Malfunction
    Date Received
    November 21, 2020
    Date of Event
    October 23, 2020
    Report Date
    December 4, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095750
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: FOUR PHOTOS DISPLAYING 3ML BLISTER PACKS AND 100-COUNT SHELF CARTONS WERE RECEIVED AND EVALUATED. ONE CARTON AND BLISTER PACK WERE FROM BATCH: 9111106 (P/N: 309575). ONE CARTON AND BLISTER PACK WERE FROM BATCH: 1053817 (P/N: 309571). NO DEFECTS WERE OBSERVED IN ANY OF THE PHOTOS. BASED ON THE INFORMATION ON THE LABELS FROM BATCH: 9111106 AND 1053817, THE PRODUCT WAS MANUFACTURED IN 2009 AND 2010 RESPECTIVELY. THESE BATCHES WERE MANUFACTURED PRIOR TO THE UDI REQUIREMENTS THAT MANDATED MARKING INDIVIDUAL PACKAGING WITH EXPIRATION DATE. THESE BATCHES WERE MANUFACTURED CORRECTLY PER PRODUCT DESIGN AT THAT TIME. PLEASE NOTE BATCHES: 9111106 AND 1053817 WERE EXPIRED AS OF 2014 AND 2015 AND BD DOES NOT MAKE CLAIMS ABOUT THE PERFORMANCE OR EFFICACY OF EXPIRED PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 3ML LL W/NDL 21X1 RB HAD NO EXPIRATION DATE ON ITS PACKAGING, NOR DID THE BOX IT CAME IN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE 6 BOXES OF SYRINGES (100 COUNT PER BOX) THAT DO NOT HAVE AN EXPIRATION DATE ON THE BOX AND PACKAGING".

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. 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 3ML LL W/NDL 21X1 RB HAD NO EXPIRATION DATE ON ITS PACKAGING, NOR DID THE BOX IT CAME IN. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I HAVE 6 BOXES OF SYRINGES (100 COUNT PER BOX) THAT DO NOT HAVE AN EXPIRATION DATE ON THE BOX AND PACKAGING".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1346235 SYRINGE 3ML LL W/NDL 21X1 RB PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309575 9111106 30382903095750

    Patients

    Seq Age Sex Outcome Treatment
    1