BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 11742713 · Received April 28, 2021

    Report

    Report Number
    1213809-2021-00277
    Event Type
    Malfunction
    Date Received
    April 28, 2021
    Date of Event
    April 1, 2021
    Report Date
    June 17, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE PHOTO DISPLAYING A TOTAL OF EIGHT 3ML SYRINGES IN FULLY SEALED BLISTER PACKS WAS RECEIVED AND EVALUATED. IT WAS OBSERVED SEVEN OF THE SYRINGES IN THE PHOTO WERE MISSING LARGE AMOUNTS OF PRINT. ONE SYRINGE WAS COMPLETELY BLANK, FIVE SYRINGES ONLY HAD SMALL AMOUNT OF PRINT AROUND THE 2ML MARKING, ONE SYRINGE HAD NO PRINT ABOVE THE 1.5ML MARKING, AND ONE SYRINGE WAS BARELY VISIBLE IN THE PHOTO. SEVEN OF THE SYRINGES WERE CONFIRMED TO BE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. IT WAS LIKELY DUE TO AN INK FLOW ISSUE THAT PREVENTED THE PROPER AMOUNT OF INK FROM BEING APPLIED. MISSING PRINT WAS FOUND DURING THE MANUFACTURE OF THIS BATCH AND A REQUALIFICATION WAS PERFORMED. IT IS POSSIBLE A LIMITED NUMBER OF PIECES WERE ABLE TO ESCAPE DETECTION. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 1041510 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 6/7/2021. H.6. INVESTIGATION: FIVE 3ML SYRINGES (P/N 309657) IN SEALED BLISTERPAKS FROM BATCH #1041510 AND ONE PHOTO DISPLAYING A TOTAL OF EIGHT 3ML SYRINGES IN FULLY SEALED BLISTER PACKS WERE RECEIVED AND EVALUATED. THE 3ML SYRINGES RECEIVED DID NOT APPEAR TO HAVE ANY VISIBLE DEFECTS. IT WAS OBSERVED THAT SEVEN OF THE SYRINGES IN THE PHOTO WERE MISSING LARGE AMOUNTS OF PRINT. ONE SYRINGE WAS COMPLETELY BLANK, FIVE SYRINGES ONLY HAD SMALL AMOUNT OF PRINT AROUND THE 2ML MARKING, ONE SYRINGE HAD NO PRINT ABOVE THE 1.5ML MARKING, AND ONE SYRINGE WAS BARELY VISIBLE IN THE PHOTO. SEVEN OF THE SYRINGES WERE CONFIRMED TO BE REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. IT WAS LIKELY DUE TO AN INK FLOW ISSUE THAT PREVENTED THE PROPER AMOUNT OF INK FROM BEING APPLIED. MISSING PRINT WAS FOUND DURING THE MANUFACTURE OF THIS BATCH AND A REQUALIFICATION WAS PERFORMED. IT IS POSSIBLE A LIMITED NUMBER OF PIECES WERE ABLE TO ESCAPE DETECTION. DHR WAS PERFORMED. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH MISSING PRINT DEFECTS REPORTED. BATCH 1041510 WAS REQUALIFIED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 BD 60ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES NOT USABLE AS THEY DO NOT HAVE ANY PRINT, OR ONLY PARTIAL PRINT WE RECEIVED THE ATTACHED CONCERN REGARDING 8 CASES 309657 LOT 1041510 WHICH ARE MISSING THE GRADUATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 BD 60ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES NOT USABLE AS THEY DON'T HAVE ANY PRINT, OR ONLY PARTIAL PRINT WE RECEIVED THE ATTACHED CONCERN REGARDING 8 CASES 309657, LOT 1041510 WHICH ARE MISSING THE GRADUATIONS.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 8 BD 60ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGES NOT USABLE AS THEY DON'T HAVE ANY PRINT, OR ONLY PARTIAL PRINT WE RECEIVED THE ATTACHED CONCERN REGARDING 8 CASES 309657 LOT 1041510 WHICH ARE MISSING THE GRADUATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632818 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1041510

    Patients

    Seq Age Sex Outcome Treatment
    1