BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK

    MDR report key: 18540105 · Received January 18, 2024

    Report

    Report Number
    1213809-2024-00010
    Event Type
    Malfunction
    Date Received
    January 18, 2024
    Date of Event
    November 20, 2023
    Report Date
    July 3, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903059004
    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

    BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. ADDRESS IS B)(6) WAS USED. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MATERIALS#: 305900 BATCH#: 1160596 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PROBLEM: 1. IT MAY BE VERY DIFFICULT TO PUSH MEDICATION THROUGH THE ABOVE LOT OF BD SAFETYGLIDE 22 G NEEDLES. 2. THE DEFECTIVE NEEDLES MAY CAUSE PATIENT AND ADMINISTRATOR DISCOMFORT. 3. THE FORCE REQUIRED TO ADMINISTER THE INJECTION MAY CAUSE MEDICATION LEAKAGE AND PATIENT INJURY. BD SAFETYGLIDE 25 G X 1-INCH NEEDLES: LOT =2025239 25 G X 1-INCH SAFETYGLIDE SHIELDING HYPODERMIC NEEDLES REF#(B)(4) LOT = REGN2117 SAFETYGUIDE SHIELDING HYPODERMIC NEEDLES REF# (B)(4) LOT=1160596 PER CUSTOMER RESPONSE 03JAN2024: IS THIS IN REGARD TO THE BD SAFETYGLIDE 25G X 1¿ NEEDLES? WE DO NOT CARRY THE 22G. I DID NOT PLACE A REPORT THAT IT WAS DIFFICULT TO PUSH A MEDICATION THROUGH. THERE WAS A RECALL ON SOME LOT NUMBERS OF BD SAFETYGLIDE 25G X 1¿ NEEDLES AND I REPORTED TO MY LOGISTICS TEAM THAT THOUGH I DID NOT HAVE THOSE SPECIFIC LOTS, I FELT THE NEEDLES AND SAFETY WERE FLIMSY ON THIS BRAND, WITH A POTENTIAL RISK FOR NEEDLE STICKS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAFETY-LOK NEEDLES WERE CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VERY DIFFICULT TO PUSH MEDICATION THROUGH THE ABOVE LOT OF BD SAFETYGLIDE 22 G NEEDLES." PROBLEM: 1. IT MAY BE VERY DIFFICULT TO PUSH MEDICATION THROUGH THE ABOVE LOT OF BD SAFETYGLIDE 22 G NEEDLES. 2. THE DEFECTIVE NEEDLES MAY CAUSE PATIENT AND ADMINISTRATOR DISCOMFORT. 3. THE FORCE REQUIRED TO ADMINISTER THE INJECTION MAY CAUSE MEDICATION LEAKAGE AND PATIENT INJURY. BD SAFETYGLIDE 25 G X 1-INCH NEEDLES : LOT =2025239 25 G X 1-INCH SAFETYGLIDE SHIELDING HYPODERMIC NEEDLES REF# (B)(4), LOT = REGN2117. SAFETYGUIDE SHIELDING HYPODERMIC NEEDLES REF# (B)(4), LOT=1160596.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1773314 BD SAFETY-LOK SAFETYGLIDE NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 1160596 30382903059004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown