BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE

    MDR report key: 13497152 · Received February 9, 2022

    Report

    Report Number
    1213809-2022-00060
    Event Type
    Malfunction
    Date Received
    February 9, 2022
    Date of Event
    January 24, 2022
    Report Date
    March 9, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096580
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 2022-03-01. H6: INVESTIGATION SUMMARY: ONE SAMPLE OF A 3ML LUER-LOK EUROGRAPHIC SYRINGE (309658) WAS RECEIVED AND EVALUATED. THE PLUNGER ROD WAS REMOVED FROM THE STOPPER UPON RECEIVING. THE PLUNGER WAS PLACED BACK INTO THE STOPPER AND EASILY PULLED OUT WITH THE STOPPER REMAINING INSIDE THE BARREL AT THE TIP OF THE SYRINGE. UPON EXAMINATION OF THE PLUNGER ROD, IT IS DETERMINED THAT THERE WAS INCOMPLETE FILL OF TIP FROM MOLDING. THE OBSERVED CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATIONS. POTENTIAL ROOT CAUSE FOR THE INCOMPLETE FILL OF TIP DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH 0133147 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 PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE PLUNGER BROKE DURING USE AND SEPARATED FROM THE STOPPER, WHICH REMAINED INSIDE THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLUNGER BROKE DURING USE DURING ASPIRATION OF A DRUG, THE PLUNGER BROKE OFF AND DISCONNECTED WITH THE STOPPER. THE STOPPER REMAINED INSIDE THE SYRINGE BARREL."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE PLUNGER BROKE DURING USE AND SEPARATED FROM THE STOPPER, WHICH REMAINED INSIDE THE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PLUNGER BROKE DURING USE DURING ASPIRATION OF A DRUG, THE PLUNGER BROKE OFF AND DISCONNECTED WITH THE STOPPER. THE STOPPER REMAINED INSIDE THE SYRINGE BARREL."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837742 BD PLASTIPAK¿ LUER-LOK¿ TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309658 0133147 30382903096580

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown