BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK TIP BULK CONVENIENCE PAK

    MDR report key: 11978668 · Received June 10, 2021

    Report

    Report Number
    1213809-2021-00417
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 14, 2021
    Report Date
    June 1, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096047
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: NA. INVESTIGATION SUMMARY: THREE PHOTOS WERE RECEIVED AND EVALUATED. TWO PHOTOS SHOWED SEVERAL 10ML SYRINGES (P/N (B)(4)) IN A BOX. BOTH THE TOP WEB AND BOTTOM WEB WERE VISIBLE ON SEVERAL SAMPLES. ONE PHOTO SHOWED A BD LABEL FOR 10ML SYRINGES ON A BOX WITH THE SYRINGE LOT NUMBER IN THE BOTTOM RIGHT-HAND CORNER. BASED ON THE INFORMATION, BATCH #0033237 WAS LIKELY MANUFACTURED IN 2000. THIS BATCH WAS MANUFACTURED PRIOR TO THE UNIQUE DEVICE IDENTIFIER REQUIREMENTS THAT MANDATED MARKING INDIVIDUAL PACKAGING WITH EXPIRATION DATE. THIS BATCH WAS MANUFACTURED CORRECTLY PER PRODUCT DESIGN AT THAT TIME. PLEASE NOTE BATCH #0033237 WAS EXPIRED AS OF 2005 AND BD DOES NOT MAKE CLAIMS ABOUT THE PERFORMANCE OR EFFICACY OF EXPIRED PRODUCTS. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD 10ML SYRINGE LUER-LOK¿ TIP BULK CONVENIENCE PAK EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 309604, BATCH NO.: 0033237. MISSING EXPIRATION DATE ON SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871988 BD 10ML SYRINGE LUER-LOK TIP BULK CONVENIENCE PAK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309604 0033237 30382903096047

    Patients

    Seq Age Sex Outcome Treatment
    1