BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 9297430 · Received November 8, 2019

    Report

    Report Number
    2243072-2019-02505
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 10, 2019
    Report Date
    November 25, 2019
    Manufacturer
    BECTON DICKINSON
    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

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, 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 2 SYRINGE 3ML LL 200 S/C EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309657 BATCH NO. : UNKNOWN (PROVIDED: M314253) THIS REPORT REPRESENTS ALL AVAILABLE PRODUCT INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE. 1. DESCRIPTION OF ISSUE: CUSTOMER REPORTED DEBRIS IN 2 SYRINGES WHEN FILLING A NEW CARTRIDGE 2. NUMBER OF OCCURRENCES: 2 3. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 4. 4. ITEM NUMBER: 3 ML SYRINGE ¿ 309657 5. PRODUCT LOT NUMBER: UNKNOWN 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 CUSTOMER WAS ABLE TO FILL THE CARTRIDGE SUCCESSFULLY WITH OTHER NEEDLES. CONTACT DESCRIBED THE DEBRIS AS LITTLE PIECES OF PLASTIC CONTACT SAID SHE NOTICED THEM WHEN SHE WAS GOING TO FILL THE CARTRIDGE, AND DECIDED NOT TO USE THOSE SYRINGES/NEEDLES THEY SAW THE DEBRIS.

    Additional Manufacturer Narrative · 1

    PMA/510(K)#: WITHOUT KNOWING THE MANUFACTURE SITE, THE PMA/510(K) COULD BE EITHER K980987 OR K151766. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(6). 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 2 SYRINGE 3ML LL 200 S/C EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309657 BATCH NO. : UNKNOWN. (PROVIDED: M314253). THIS REPORT REPRESENTS ALL AVAILABLE PRODUCT INFORMATION. NO ADDITIONAL INFORMATION IS AVAILABLE. DESCRIPTION OF ISSUE: CUSTOMER REPORTED DEBRIS IN 2 SYRINGES WHEN FILLING A NEW CARTRIDGE. NUMBER OF OCCURRENCES: 2. 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: UNKNOWN. 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. CUSTOMER WAS ABLE TO FILL THE CARTRIDGE SUCCESSFULLY WITH OTHER NEEDLES. CONTACT DESCRIBED THE DEBRIS AS LITTLE PIECES OF PLASTIC. CONTACT SAID SHE NOTICED THEM WHEN SHE WAS GOING TO FILL THE CARTRIDGE, AND DECIDED NOT TO USE THOSE SYRINGES/NEEDLES THEY SAW THE DEBRIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088746 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Other