BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER SLIP TIP SYRINGE STERILE, SINGLE USE,

    MDR report key: 16781764 · Received April 20, 2023

    Report

    Report Number
    1213809-2023-00389
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    March 21, 2023
    Report Date
    May 4, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096597
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E4: THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 21-MAR-2023. MEDWATCH REPORT # MW5115971 H3: A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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: 26-APR-2023. H6: INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A BROWNISH-RED EMBEDDED SPOTS WERE OBSERVED. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START UP. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE RISK TO THE CUSTOMER. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2203500. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ LUER SLIP TIP SYRINGE STERILE, SINGLE USE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I NOTICED VISIBLE CONTAMINATION ON AN UNOPENED STERILE BD 1 ML TUBERCULIN SLIP-TIP SYRINGE (REF (B)(4)). THE LOT NUMBER IS 2203500. OUR LAB USES THESE SYRINGES IN PROKARYOTIC MICROBIAL RESEARCH WITH NO DIRECT HUMAN HEALTH APPLICATIONS. I CAN'T ASCERTAIN WHETHER THE RESIDUE IS ONLY ON THE OUTSIDE OF THE SYRINGE OR ACTUALLY INSIDE THE TIP WITHOUT OPENING THE STERILE WRAPPER. ALL I CAN SAY WITH CERTAINTY IS THAT THE DISCOLORATION IS ON THE SYRINGE ITSELF, NOT JUST THE INSIDE OF THE PACKAGING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD¿ LUER SLIP TIP SYRINGE STERILE, SINGLE USE FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I NOTICED VISIBLE CONTAMINATION ON AN UNOPENED STERILE BD 1 ML TUBERCULIN SLIP-TIP SYRINGE (REF (B)(4)). THE LOT NUMBER IS 2203500. OUR LAB USES THESE SYRINGES IN PROKARYOTIC MICROBIAL RESEARCH WITH NO DIRECT HUMAN HEALTH APPLICATIONS. I CAN'T ASCERTAIN WHETHER THE RESIDUE IS ONLY ON THE OUTSIDE OF THE SYRINGE OR ACTUALLY INSIDE THE TIP WITHOUT OPENING THE STERILE WRAPPER. ALL I CAN SAY WITH CERTAINTY IS THAT THE DISCOLORATION IS ON THE SYRINGE ITSELF, NOT JUST THE INSIDE OF THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1206238 BD¿ LUER SLIP TIP SYRINGE STERILE, SINGLE USE, PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309659 2203500 30382903096597

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown