BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 26X3/8 IB

    MDR report key: 11152545 · Received January 11, 2021

    Report

    Report Number
    1911916-2021-00016
    Event Type
    Malfunction
    Date Received
    January 11, 2021
    Date of Event
    December 5, 2020
    Report Date
    January 7, 2021
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051107
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    "INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 305110 AND LOT NUMBER 9193538. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 3 NEEDLE 26X3/8 IB HAD FOREIGN MATTER DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE NEEDLES ARE BLOCKED AND CORING. (B)(4). "DISTRIBUTOR NAME: (B)(4). TANDEM DISTRIBUTOR ACCOUNT NUMBER: (B)(4). DISTRIBUTOR INCIDENT REFERENCE NUMBER: (B)(4). COUNTRY OF EVENT: (B)(6). DATE DISTRIBUTOR NOTIFIED: (B)(6) 2020. INCIDENT INFORMATION: EVENT DATE: (B)(6) 2020. INCIDENT CATEGORY: POWER SOURCE ALERT 7 + BATTERY JUMPS ((B)(4) NOT RELATED TO SYRINGE/NEEDLE ISSUE). EVENT DETAILS (ATTACH ADDITIONAL PAGES IF NEEDED AND DO NOT INCLUDE THE PERSONAL DATA OF ANY INDIVIDUAL): NEEDLE ISSUES: DESCRIPTION OF ISSUE: CUSTOMER REPORTS SYRINGE GOT BLOCKED. NUMBER OF OCCURRENCES: 2. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? YES. BD WILL NOT CONTACT THE CUSTOMER. WHICH NEEDLE IS THE CUSTOMER USING? BD 26 G, 3/8¿ NEEDLE ¿ 305110. NEEDLE LOT NUMBER: ASKU. WHAT WAS YOUR BG READING AT THE TIME OF THIS EVENT? WITHIN RANGE. PATIENT INFORMATION: AGE AT TIME OF EVENT: NA. AGE UNITS: NA. GENDER: NA. PRODUCT INFORMATION: SERIAL NUMBER: (B)(4). CARTRIDGE LOT NUMBER: NA. INSULIN USED: NA. INFUSION SET BRAND: NA. INFUSION SET PART NUMBER: NA. INFUSION SET LOT NUMBER: NA. IS DEVICE BEING RETURNED? NO. EXPECTED RETURN DATE: 7 BUSINESS DAYS AFTER DATE DISTRIBUTOR NOTIFIED DISTRIBUTOR¿S RETURN REFERENCE NUMBER (PROVIDED BY CMD): 7 BUSINESS DAYS AFTER DATE DISTRIBUTOR NOTIFIED. REPLACEMENT PUMP SERIAL NUMBER: NA. HEALTHCARE FACILITY INFORMATION: NAME OF FACILITY: NA. ADDRESS: NA. CITY: NA STATE/PROVINCE: NA. COUNTRY: NA. EMAIL: NA. PHONE: NA. FAX: NA. PER DISTRIBUTOR: DID CUSTOMER ONLY CHANGE THE SYRINGE NEEDLES TO RESOLVE THE NEEDLE BLOCKAGE ISSUE? I APOLOGISE, THE ANSWER FOR THIS QUESTION SHOULD BE YES. " (B)(4). "DISTRIBUTOR COMPLAINT REPORT - INTERNATIONAL. DISTRIBUTOR INFORMATION: DISTRIBUTOR NAME: (B)(4). TANDEM DISTRIBUTOR ACCOUNT NUMBER: (B)(4) DISTRIBUTOR INCIDENT REFERENCE NUMBER: COUNTRY OF EVENT: (B)(6). DATE DISTRIBUTOR NOTIFIED: (B)(6) 2020. INCIDENT INFORMATION: EVENT DATE: (B)(6) 2020. INCIDENT CATEGORY: FILL RESISTANCE. EVENT DETAILS (ATTACH ADDITIONAL PAGES IF NEEDED AND DO NOT INCLUDE THE PERSONAL DATA OF ANY INDIVIDUAL): DESCRIPTION OF ISSUE:FILLING CARTRIDGE ENCOUNTERED FILL RESISTANCE. NUMBER OF OCCURRENCES: 5. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? YES. BD WILL NOT CONTACT THE CUSTOMER. WHICH NEEDLE IS THE CUSTOMER USING? CHOOSE ONE: BD 26 G, 3/8¿ NEEDLE ¿ 305110. NEEDLE LOT NUMBER: M567696. WHAT WAS YOUR BG READING AT THE TIME OF THIS EVENT? WITHIN RANGE. WAS CUSTOMER ABLE TO LOAD A NEW CARTRIDGE? YES. EXAMPLE: CUSTOMER CHANGED ONLY THE NEEDLE AND WAS ABLE TO FILL THE CARTRIDGE SUCCESSFULLY. NO FURTHER TANDEM FOLLOW UP IS REQUIRED. NOTE: PRODUCT CATEGORY = FILL RESISTANCE. STOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    42584 NEEDLE 26X3/8 IB HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 305110 UNKNOWN 30382903051107

    Patients

    Seq Age Sex Outcome Treatment
    1