BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 5ML SYRINGE LUER-LOK TIP

    MDR report key: 11248949 · Received January 28, 2021

    Report

    Report Number
    1213809-2021-00046
    Event Type
    Malfunction
    Date Received
    January 28, 2021
    Date of Event
    January 5, 2021
    Report Date
    February 8, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096497
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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: 2/1/2021. H.6. INVESTIGATION: RECEIVED 2 SYRINGES IN A BIOHAZARD BAG. BLISTERS WERE OPENED. ONE SYRINGE WAS PLACED INSIDE OPENED PACKAGE. ONE SYRINGE WAS OUTSIDE OF THE PACKAGE. BOTH SYRINGES WERE CONFIRMED TO HAVE A CRACK BETWEEN THE ZERO AND THE 3ML LINE. BOTH PACKAGES WERE FROM THE SAME BATCH # 0213256. 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. POTENTIAL ROOT CAUSE FOR THE CRACKED BARREL DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD 5ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OBSERVATION OF A CRACK IN THE BODY OF 2 SYRINGES USED AT THE TIME OF PPI WATER SAMPLING FOR CYTOTOXIC RECONSTITUTION. NO CONSEQUENCES FOR STAFF OR PATIENTS. PRECAUTIONARY MEASURES AND ACTIONS TAKEN : SYRINGES QUARANTINED, THE DEVICES HAVE NOT BEEN IN CONTACT WITH A CYTOTOXIC AGENT. QUARANTINE OF THE BATCH CONCERNED.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD 5ML SYRINGE LUER-LOK¿ TIPS EXPERIENCED DEVICE DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: OBSERVATION OF A CRACK IN THE BODY OF 2 SYRINGES USED AT THE TIME OF PPI WATER SAMPLING FOR CYTOTOXIC RECONSTITUTION. NO CONSEQUENCES FOR STAFF OR PATIENTS PRECAUTIONARY MEASURES AND ACTIONS TAKEN : SYRINGES QUARANTINED, THE DEVICES HAVE NOT BEEN IN CONTACT WITH A CYTOTOXIC AGENT QUARANTINE OF THE BATCH CONCERNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145218 BD 5ML SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0213256 00382903096497

    Patients

    Seq Age Sex Outcome Treatment
    1