BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 12100690 · Received July 1, 2021

    Report

    Report Number
    1213809-2021-00465
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    June 2, 2021
    Report Date
    July 23, 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: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/22/2021. H.6. INVESTIGATION: ONE PHOTO, ONE VIDEO SHOWING A LEAKING 3ML SYRINGE (P/N 309657) WITH CUSTOMER ATTACHED NEEDLE, AND TWO SAMPLES WITH TWO STRIPS OF TOP WEB FROM BATCH #0122547 WERE RECEIVED. THE SAMPLES WERE VISUALLY EVALUATED. A LARGE VERTICAL CRACK OUTSIDE OF THE PRINT AREA COULD BE SEEN EXTENDING FROM BETWEEN THE 1ML AND 1.5ML GRAD LINES TO JUST BEFORE THE ZERO LINE ON ONE SAMPLE. ONE SAMPLE HAD A LARGE VERTICAL CRACK INSIDE THE PRINT AREA EXTENDING FROM JUST BEFORE THE 1.5ML GRAD LINE TO JUST BEFORE THE ZERO LINE. THE OBSERVED DAMAGE WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH #0122547 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD 60ML SYRINGE LUER-LOK¿ TIP EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: 0122547. ONCE NORMAL SALINE DRAWN INTO SYRINGE, SALINE LEAKED OUT OF A CRACK IN THE SIDE OF THE SYRINGE. WHO WAS AFFECTED?: NO PERSON AFFECTED. FREQUENCY OF PROBLEM: FIRST TIME.

    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 THE BD 60ML SYRINGE LUER-LOK¿ TIP EXPERIENCED DEVICE DAMAGE WHILE STILL CONSIDERED OPERABLE, AND LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: 0122547. ONCE NORMAL SALINE DRAWN INTO SYRINGE, SALINE LEAKED OUT OF A CRACK IN THE SIDE OF THE SYRINGE. WHO WAS AFFECTED?: NO PERSON AFFECTED. FREQUENCY OF PROBLEM: FIRST TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    999104 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 0122547 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1