BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 13006745 · Received December 14, 2021

    Report

    Report Number
    1213809-2021-00817
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 18, 2021
    Report Date
    December 27, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059035
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. COMMON DEVICE NAME: AN ADDITIONAL COMMON DEVICE NAME OF PISTON SYRINGE ALSO APPLIES TO THIS DEVICE. MEDICAL DEVICE TYPE: AN ADDITIONAL MEDICAL DEVICE TYPE OF FMF ALSO APPLIES TO THIS DEVICE. PMA/510(K): AN ADDITIONAL PMA/510(K) OF K980580 ALSO APPLIES TO THIS DEVICE 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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. COMMON DEVICE NAME: AN ADDITIONAL COMMON DEVICE NAME OF PISTON SYRINGE ALSO APPLIES TO THIS DEVICE. MEDICAL DEVICE TYPE: AN ADDITIONAL MEDICAL DEVICE TYPE OF FMF ALSO APPLIES TO THIS DEVICE. PMA/510(K): AN ADDITIONAL PMA/510(K) OF K980580 ALSO APPLIES TO THIS DEVICE 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

    INVESTIGATION SUMMARY: CATALOG P/N 305903 IS MARKETED AND SOLD AS AN "INJECTION NEEDLE WITH LUER SLIP SYRINGE" PER THE UNIT PRODUCT PACKAGING. NOTE THAT THE PRODUCT INSTRUCTIONS FOR USE STATE TO "PUSH FIRMLY WHEN ATTACHING THE NEEDLE TO THE SYRINGE", THIS WILL HELP ENSURE AN ADEQUATE CONNECTION TO THE SLIP TIP SYRINGE. THERE ARE A FEW FUNDAMENTAL DIFFERENCES BETWEEN LUER-LOCK AND LUER-SLIP SYRINGES. THE LUER-LOCK SYRINGES REQUIRE THE TABBED HUBS OF THE NEEDLE TO SCREW INTO THE THREADS NORMALLY PRESENT WITHIN THE COLLAR. THE LUER-SLIP SYRINGE WHILE MAINTAINING THE SAME LUER TIP TAPER AS THE LUER-LOCK IS DESIGNED TO NOT INCLUDE THE COLLAR AND LOCKING THREADS. THE NEEDLE AND SYRINGE ARE INSTEAD PRESSED TOGETHER AND HELD TOGETHER BY FRICTION. SINCE THE REPORTED CONDITION IS NOT A TRUE DEFECT AND A DESIGN-RELATED INQUIRY A POTENTIAL ROOT CAUSE COULD NOT BE ESTABLISHED, DHR REVIEW IS NOT APPLICABLE, AND CORRECTIVE ACTIONS ARE NOT NECESSARY. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE EXPERIENCED LEAKAGE, AND A NEEDLE THAT WAS PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ATTACHING NEEDLE TO SYRINGE, THERE ISN'T A LUER LOCK TO HOLD THE NEEDLE IN PLACE ON SYRINGE DURING ADMINISTRATION. AN INJECTION TO A PATIENT IN PEDIATRICS, THE NEEDLE STAYED IN THE PATIENT WHEN WITHDRAWING THE SYRINGE. NO IMPACT TO PATIENT. SYRINGE ALSO LEAKS SINCE THERE ISN'T A LUER LOCK PRESENT AND PATIENTS MAY NOT BE RECEIVING FULL DOSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE EXPERIENCED LEAKAGE, AND A NEEDLE THAT WAS PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ATTACHING NEEDLE TO SYRINGE, THERE ISN'T A LUER LOCK TO HOLD THE NEEDLE IN PLACE ON SYRINGE DURING ADMINISTRATION. AN INJECTION TO A PATIENT IN PEDIATRICS, THE NEEDLE STAYED IN THE PATIENT WHEN WITHDRAWING THE SYRINGE. NO IMPACT TO PATIENT. SYRINGE ALSO LEAKS SINCE THERE ISN'T A LUER LOCK PRESENT AND PATIENTS MAY NOT BE RECEIVING FULL DOSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE EXPERIENCED LEAKAGE, AND A NEEDLE THAT WAS PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN ATTACHING NEEDLE TO SYRINGE, THERE ISN'T A LUER LOCK TO HOLD THE NEEDLE IN PLACE ON SYRINGE DURING ADMINISTRATION. AN INJECTION TO A PATIENT IN PEDIATRICS, THE NEEDLE STAYED IN THE PATIENT WHEN WITHDRAWING THE SYRINGE. NO IMPACT TO PATIENT. SYRINGE ALSO LEAKS SINCE THERE ISN'T A LUER LOCK PRESENT AND PATIENTS MAY NOT BE RECEIVING FULL DOSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1896963 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH ATTACHED NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 305903 1041340 30382903059035

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown