BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 26X3/8 IB

    MDR report key: 8725576 · Received June 23, 2019

    Report

    Report Number
    1911916-2019-00619
    Event Type
    Malfunction
    Date Received
    June 23, 2019
    Date of Event
    May 24, 2019
    Report Date
    June 28, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051107
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: NO SAMPLES OR PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED ON THE BATCH ASSOCIATED WITH THIS INVESTIGATION. THE DHR REVIEWS DID NOT REVEAL ANY DEFECTS OR ISSUES REPORTED AND NO QUALITY NOTIFICATIONS WERE ISSUED. BASED ON THE INVESTIGATION CONCLUSION AND WITHOUT A SAMPLE TO ANALYZE, THE CONDITION REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED NOR COULD THIS SYMPTOM BE CORRELATED WITH A POTENTIAL CAUSE LINKED TO THE BD PROCESS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE 26X3/8 IB EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305110; BATCH NO. 8172842. 1. DESCRIPTION OF ISSUE: CUSTOMER CALLED IN REPORTING THEIR SYRINGE WAS LEAKING INSULIN WHEN THEY WERE FILLING IT WITH INSULIN FROM THE VIAL. 2. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. 3. NUMBER OF OCCURRENCES: 1. 4. ITEM NUMBER: 26 G, 3/8¿ NEEDLE ¿ 305110. 5. PRODUCT LOT NUMBER: 8172842. 6. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? YES . 7. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? NO. 8. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO. 9. RESOLUTION: BD MIGHT FOLLOW UP WITH CUSTOMER REGARDING RETURNING SYRINGE/NEEDLE. NO FURTHER DISTRIBUTOR FOLLOW UP IS REQUIRED. CUSTOMER REQUESTED REPLACEMENT FOR SYRINGE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 THAT THE NEEDLE 26X3/8 IB EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305110 BATCH NO. 8172842 DESCRIPTION OF ISSUE: CUSTOMER CALLED IN REPORTING THEIR SYRINGE WAS LEAKING INSULIN WHEN THEY WERE FILLING IT WITH INSULIN FROM THE VIAL. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. NUMBER OF OCCURRENCES: 1. ITEM NUMBER: 26 G, 3/8¿ NEEDLE ¿ 305110. PRODUCT LOT NUMBER: 8172842. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES. DOES CUSTOMER AUTHORIZE BD TO CONTACT CUSTOMER TO OBTAIN SAMPLE(S)? YES. DID ISSUE CAUSE ANY INJURY? IF YES, WHAT TYPE OF INJURY? NO. MEDICAL INTERVENTION NEEDED? IF YES, WHO WAS THE 3RD PARTY AND WHAT WAS THE ASSISTANCE/TREATMENT? NO. RESOLUTION: BD MIGHT FOLLOW UP WITH CUSTOMER REGARDING RETURNING SYRINGE/NEEDLE. NO FURTHER DISTRIBUTOR FOLLOW UP IS REQUIRED. CUSTOMER REQUESTED REPLACEMENT FOR SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    519142 NEEDLE 26X3/8 IB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8172842 30382903051107

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other