BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 9355736 · Received November 21, 2019

    Report

    Report Number
    2243072-2019-02615
    Event Type
    Malfunction
    Date Received
    November 21, 2019
    Date of Event
    October 24, 2019
    Report Date
    November 26, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    SEE H.10
    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

    MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON MEDICAL SYSTEMS - CANAAN, CT / 06018. MANUFACTURING LOCATION: BECTON DICKINSON MEDICAL SYSTEMS - CANAAN, CT / 06018. INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, SO WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS LOT NUMBER WAS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL 200 S/C EXPERIENCED LEAKAGE AT THE CONNECTION SITE WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657; BATCH NO: UNKNOWN. EVENT DESCRIPTION: SUBJECT: CTS CLARIFICATION 1. DESCRIPTION OF ISSUE: CUSTOMER REPORTED EVER SINCE THEY HAVE USED THE TANDEM PUMP, INSULIN WILL LEAK OUT OF THE CREASE B/W THE SYRINGE AND NEEDLE. 2. NUMBER OF OCCURRENCES: CUSTOMER COULD NOT PROVIDE A SPECIFIC NUMBER. 3. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? O NO. PROCEED TO STEP 4. 4. ITEM NUMBER: 3 ML SYRINGE ¿ 309657. 5. PRODUCT LOT NUMBER: COULD NOT PROVIDE. 6. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? O NO. 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? N/A. 9. RESOLUTION? CUSTOMER DID NOT ALLEGE AN ACTUAL ISSUE WITH THE PRODUCT BUT THAT THEY BELIEVE IT SHOULD THE SYRINGE AND NEEDLE SHOULD COME TOGETHER AS 1 UNIT AS SHE DOES NOT ALWAYS TIGHTEN IT SECURELY WHICH CAUSES THE LEAKING OF INSULIN.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. PMA/510(K)#: WITHOUT KNOWING THE MANUFACTURING LOCATION, THE PMA/510(K) # COULD EITHER BE K980987 OR K151766. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 3ML LL 200 S/C EXPERIENCED LEAKAGE AT THE CONNECTION SITE WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO: 309657 BATCH NO: UNKNOWN. EVENT DESCRIPTION: SUBJECT: CTS CLARIFICATION. DESCRIPTION OF ISSUE: CUSTOMER REPORTED EVER SINCE THEY HAVE USED THE TANDEM PUMP, INSULIN WILL LEAK OUT OF THE CREASE B/W THE SYRINGE AND NEEDLE. NUMBER OF OCCURRENCES: CUSTOMER COULD NOT PROVIDE A SPECIFIC NUMBER. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 4. ITEM NUMBER: 3 ML SYRINGE ¿ 309657. PRODUCT LOT NUMBER: COULD NOT PROVIDE. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? NO. 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? N/A. RESOLUTION: CUSTOMER DID NOT ALLEGE AN ACTUAL ISSUE WITH THE PRODUCT BUT THAT THEY BELIEVE IT SHOULD THE SYRINGE AND NEEDLE SHOULD COME TOGETHER AS 1 UNIT AS SHE DOES NOT ALWAYS TIGHTEN IT SECURELY WHICH CAUSES THE LEAKING OF INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1154035 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Other