BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 12565173 · Received October 1, 2021

    Report

    Report Number
    1213809-2021-00686
    Event Type
    Malfunction
    Date Received
    October 1, 2021
    Date of Event
    August 18, 2021
    Report Date
    October 26, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095972
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: TWO THUMBNAILS OF PHOTOS WERE RECEIVED AND EVALUATED. THE PHOTOS SHOWED A 1ML S/T SYRINGE WITH A NEEDLE ATTACHED. NO DEFECTS COULD BE OBSERVED IN THE PHOTOS. PHYSICAL SAMPLES ARE NECESSARY FOR EVALUATION OF POTENTIAL CLOGGED NEEDLE. POTENTIAL ROOT CAUSE FOR CLOGGED NEEDLE DEFECT IS ASSOCIATED WITH THE NEEDLE SUPPLIER¿S MANUFACTURING PROCESS. THE PHOTOS WERE FORWARDED TO THE NEEDLE SUPPLIER FOR FURTHER EVALUATION AND INVESTIGATION. FURTHER EVALUATION PERFORMED AT NEEDLE MANUFACTURING SITE. BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. SINCE NO PHYSICAL SAMPLES WERE RECEIVED FOR ANALYSIS, POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBERS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE , THE DEVICE EXPERIENCED A CLOGGED/BLOCKED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PATIENT STATED SHE IS HAVING TROUBLE WITH ALL HER SUBQ NEEDLES. PATIENT STATES THEY SEEM CLOGGED OR NOT HOLLOW. SOMETIMES IF SHE PUMPS THE DOSING SYRINGE ENOUGH TIMES SOMETHING UNCLOGS AND THE INJECTION IS EASY. OTHER TIMES SHE PUMPS THE DOSING SYRINGE AND NOTHING UNCLOGS AND SHE CANNOT USE THE NEEDLE.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0080941. MEDICAL DEVICE EXPIRATION DATE: 2025-03-31. DEVICE MANUFACTURE DATE: 2020-03-20. MEDICAL DEVICE LOT #: 1019167. MEDICAL DEVICE EXPIRATION DATE: 2025-12-31. DEVICE MANUFACTURE DATE: 2021-01-19. 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 WHEN USING THE BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE , THE DEVICE EXPERIENCED A CLOGGED/BLOCKED NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: PATIENT STATED SHE IS HAVING TROUBLE WITH ALL HER SUBQ NEEDLES. PATIENT STATES THEY SEEM CLOGGED OR NOT HOLLOW. SOMETIMES IF SHE PUMPS THE DOSING SYRINGE ENOUGH TIMES SOMETHING UNCLOGS AND THE INJECTION IS EASY. OTHER TIMES SHE PUMPS THE DOSING SYRINGE AND NOTHING UNCLOGS AND SHE CANNOT USE THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460972 BD¿ SLIP-TIP SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309597 SEE H.10. 30382903095972

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown