BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 9439524 · Received December 9, 2019

    Report

    Report Number
    1911916-2019-01293
    Event Type
    Malfunction
    Date Received
    December 9, 2019
    Date of Event
    November 19, 2019
    Report Date
    December 12, 2019
    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
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TWENTY-TWO SAMPLES WERE RECEIVED FROM THE CUSTOMER FOR INVESTIGATION. THE SAMPLES WERE VISUALLY EXAMINED USING UNAIDED VISION. IT WAS OBSERVED THAT ALL THE SAMPLES HAD SMEARED PRINT ON THE 30ML GRADIENT NUMBER AND SOME OF THE SAMPLES ALSO HAD SMEARED PRINT ON THE 50ML GRADIENT NUMBER AND LETTERING. SMEARED PRINT CAN POTENTIALLY BE CAUSED BY THE FOLLOWING THREE (3) ISSUES. 1. POTENTIALLY A WORN PAD AND LOW PRESSURE. 2. SWELLING PRINTER PAD. 3. OUTFEED CHAIN OR PRINTER OUT OF TIME DUE TO JAM A DEVICE HISTORY RECORD REVIEW WAS COMPLETED WITH ZERO DEFECTS FOUND. NO QUALITY NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCHES.

    Description of Event or Problem · 0

    MATERIAL NO.: 309653. BATCH NO.: 9240105. IT WAS REPORTED THAT BEFORE USE OF THE BD 60ML SYRINGE LUER-LOK¿ TIP THE SCALE MARKINGS WERE SMUDGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HEALTH PROFESSIONAL REPORTED FINDING SEVERAL SYRINGES (QTY UNK) WITH SMUDGED SCALE MARKINGS THAT WERE UNREADABLE AND UNUSABLE, STILL IN PACKAGE.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    MATERIAL NO.: 309653, BATCH NO.: 9240105. IT WAS REPORTED THAT BEFORE USE OF THE BD 60ML SYRINGE LUER-LOK¿ TIP THE SCALE MARKINGS WERE SMUDGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HEALTH PROFESSIONAL REPORTED FINDING SEVERAL SYRINGES (QTY UNK) WITH SMUDGED SCALE MARKINGS THAT WERE UNREADABLE AND UNUSABLE, STILL IN PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1237164 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 309653 9240105 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 Other