BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 11712797 · Received April 23, 2021

    Report

    Report Number
    1213809-2021-00259
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 26, 2021
    Report Date
    May 21, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVALUATION? YES. D.10. RETURNED TO MANUFACTURER ON: 5/5/2021. H.6. INVESTIGATION: ONE PHOTO OF THREE BLISTER PACKS WAS RECEIVED AND EVALUATED. ONE OF THE BLISTER PACKS HAD THE TOP WEB FACING UP BUT THE PRODUCT INFORMATION WAS NOT LEGIBLE DUE TO LIMITED PICTURE RESOLUTION. TWO OF THE BLISTER PACKS HAD THE BOTTOM WEB FACING UP AND APPEARED TO BE FULLY SEALED, EACH WITH A 3ML SYRINGE INSIDE. IT WAS OBSERVED, THE SYRINGES HAD A LARGE DEGREE OF MISSING PRINT WITH ONE SYRINGE ONLY HAVING A FEW GRAD LINES PRESENT IN THE MIDDLE OF THE BARREL AND ONE SYRINGE HAVING GRAD LINES FROM THE ZERO LINE TO THE 1ML MARKING WITH A FEW INTERMITTENT LINES NEAR THE MIDDLE AND TOP. 162 3ML SYRINGES IN FULLY SEALED BLISTER PACKS FROM BATCH 1041510 (P/N (B)(4) WERE RECEIVED AND EVALUATED. 161 OF THE SYRINGES EXHIBITED SIMILAR PRINT DEFECTS TO THOSE SHOWN IN THE PHOTOS. ONE SYRINGE HAD NO DEFECTS. THE MISSING PRINT WAS 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. 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 151 BD LUER-LOK¿ DISPOSABLE SYRINGES WITH BD LUER-LOK¿ TIP HAD EITHER PARTIALLY VISIBLE OR MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRINTED MEASUREMENT ON SYRINGE IS MISSING OR PARTIALLY VISIBLE. SYRINGES NOT USABLE AS THEY DON'T HAVE ANY PRINT, OR ONLY PARTIAL PRINT."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 151 BD LUER-LOK¿ DISPOSABLE SYRINGES WITH BD LUER-LOK¿ TIP HAD EITHER PARTIALLY VISIBLE OR MISSING SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PRINTED MEASUREMENT ON SYRINGE IS MISSING OR PARTIALLY VISIBLE. SYRINGES NOT USABLE AS THEY DON'T HAVE ANY PRINT, OR ONLY PARTIAL PRINT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614028 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 1041510 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1