BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 9444282 · Received December 10, 2019

    Report

    Report Number
    1911916-2019-01297
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    November 20, 2019
    Report Date
    January 7, 2020
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTO SHOWS A SYRINGE IN A BAG OF SOME TYPE. THERE APPEARS TO BE BROWN FOREIGN MATTER ON THE PLUNGER ROD RIBS AND THUMB PRESS. BASED ON THE PHOTO PROVIDED IT CANNOT BE DETERMINED IF THE FOREIGN MATTER IS LOOSE OR EMBEDDED. WITHOUT A PHYSICAL SAMPLE TO ANALYZE THE FOREIGN MATTER (FM) THAT APPEARS TO BE ON THE PLUNGER ROD CANNOT BE IDENTIFIED; THEREFORE, POTENTIAL ROOT CAUSES CANNOT BE DETERMINED. 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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE TWO POTENTIAL BATCHES ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED RELATED TO THE ISSUE REPORTED BY THE CUSTOMER.

    Description of Event or Problem · 0

    MATERIAL NO: 309653 BATCH NO: UNKNOWN (POSSIBLY 9120902 OR 9120938) IT WAS REPORTED THAT DURING USE OF THE BD 60ML SYRINGE LUER-LOK¿ TIP THERE WAS AN ISSUE WITH FOREIGN MATTER. SOILED/CONTAMINATED SYRINGE - PLUNGER AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOILED/CONTAMINATED SYRINGE - PLUNGER AFFECTED. WE AREN'T CONFIDENT OF THE LOT #. THE PACKAGING WAS DISCARDED. LOTS WE HAD ON HAND THAT MIGHT HAVE BEEN THE AFFECTED LOT ARE 9120902, 9120938. THIS IS WHY I PROVIDED TWO LOT NUMBERS IN THE REPORT.

    Additional Manufacturer Narrative · 1

    THERE WERE TWO POSSIBLE LOT NUMBERS REPORTED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9120902, MEDICAL DEVICE EXPIRATION DATE: 2024-04-30, DEVICE MANUFACTURE DATE: 2019-04-30, MEDICAL DEVICE LOT #: 9120938, MEDICAL DEVICE EXPIRATION DATE: 2024-04-30, DEVICE MANUFACTURE DATE: 2019-04-30, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    MATERIAL NO: 309653 BATCH NO: UNKNOWN (POSSIBLY 9120902 OR 9120938). IT WAS REPORTED THAT DURING USE OF THE BD 60ML SYRINGE LUER-LOK¿ TIP THERE WAS AN ISSUE WITH FOREIGN MATTER. SOILED/CONTAMINATED SYRINGE - PLUNGER AFFECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOILED/CONTAMINATED SYRINGE - PLUNGER AFFECTED. WE AREN¿T CONFIDENT OF THE LOT #. THE PACKAGING WAS DISCARDED. LOTS WE HAD ON HAND THAT MIGHT HAVE BEEN THE AFFECTED LOT ARE 9120902, 9120938. THIS IS WHY I PROVIDED TWO LOT NUMBERS IN THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243475 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 UNKNOWN 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other