BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 60ML SYRINGE LUER-LOK TIP

    MDR report key: 12220917 · Received July 23, 2021

    Report

    Report Number
    1213809-2021-00517
    Event Type
    Malfunction
    Date Received
    July 23, 2021
    Date of Event
    June 16, 2021
    Report Date
    August 3, 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

    H.6. INVESTIGATION: ONE 3ML SYRINGE (P/N 309657) WITH A STRIP OF TOP WEB FROM BATCH #0122547 WAS RECEIVED. THE SAMPLE WAS VISUALLY EVALUATED. A VERTICAL CRACK ON THE BARREL EXTENDING FROM THE 1.5ML NUMERAL TO THE 2.5ML NUMERAL WAS OBSERVED. THE DAMAGE TO THE BARREL WAS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE CRACKED 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 LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONCE SODIUM CHLORIDE DRAWN INTO SYRINGE, SYRINGE LEAKED AT MIDWAY DOWN THE SYRINGE WHEN PLUNGER COMPRESSED. LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE

    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 LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ONCE SODIUM CHLORIDE DRAWN INTO SYRINGE, SYRINGE LEAKED AT MIDWAY DOWN THE SYRINGE WHEN PLUNGER COMPRESSED. LEVEL OF HARM: NO EFFECT - DID NOT REACH PATIENT - DETECTED BEFORE USE OR DOES NOT TOUCH PERSON DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115896 BD 60ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 0122547 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1