BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 3ML LL 200 S/C

    MDR report key: 8615792 · Received May 16, 2019

    Report

    Report Number
    9614033-2019-00151
    Event Type
    Malfunction
    Date Received
    May 16, 2019
    Date of Event
    April 14, 2019
    Report Date
    May 24, 2019
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K151766
    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: NO SAMPLES OR PHOTOS RECEIVED FOR INVESTIGATION. 10 PIECES OF RETENTION SAMPLES WERE INVESTIGATED FOR A VISUAL AND FUNCTIONAL EVALUATION OF THE PRODUCT TO VISUALIZE IF THE DEFECT REPORTED BY THE CUSTOMER IS PRESENT. THE RETENTION SAMPLES PRESENTED COMPLIANT RESULTS WITH NO VISUAL OR FUNCTIONAL ISSUES. NO ROOT CAUSE SINCE THE DEFECT WAS NOT CONFIRMED. THE LOT WAS INSPECTED ACCORDING TO THE CURRENT WORK INSTRUCTION WITH SATISFACTORY RESULTS FOR THE CHARACTERISTICS REQUIRED FOR ITS APPROVAL INCLUDING FUNCTIONAL TESTS. NO NON-CONFORMING PART THAT COULD BE ATTRIBUTABLE TO THE DEFECT REPORTED BY THE CLIENT WAS PRESENTED. NO DEVIATIONS (QUALITY NOTIFICATIONS) WERE REPORTED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 3ML LL 200 S/C EXPERIENCED A CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER MATERIAL NO. 309657, BATCH NO. 8222973. NO ADDITIONAL INFORMATION IS AVAILABLE. 1. DESCRIPTION OF ISSUE: CUSTOMER REPORTED SYRINGE DID NOT PULL BACK ON ITS OWN FROM CARTRIDGE. CUSTOMER TRIED DIFFERENT CARTRIDGE AND DIFFERENT SYRINGE. CUSTOMER SUSPECTS THE NEEDLE MAY NOT SCREW ON WELL TO THE SYRINGE, CUSTOMER NOT EXACTLY SURE WHAT THE ISSUE IS. 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 CHOOSE ONE: 3 ML SYRINGE ¿ 309657. 26 G, 3/8¿ NEEDLE ¿ 305110. 5. PRODUCT LOT NUMBER: 8222973. 6. ARE SAMPLES AVAILABLE FOR INVESTIGATION? YES. 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 USED A DIFFERENT NEEDLE AND COMPLETED LOAD SUCCESSFULLY WITHOUT ISSUES. 10. NOTE: PRODUCT CATEGORY = NEEDLE/SYRINGE ISSUE.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 SYRINGE 3ML LL 200 S/C EXPERIENCED A CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER MATERIAL NO. 309657, BATCH NO. 8222973. NO ADDITIONAL INFORMATION IS AVAILABLE. DESCRIPTION OF ISSUE: CUSTOMER REPORTED SYRINGE DID NOT PULL BACK ON ITS OWN FROM CARTRIDGE. CUSTOMER TRIED DIFFERENT CARTRIDGE AND DIFFERENT SYRINGE. CUSTOMER SUSPECTS THE NEEDLE MAY NOT SCREW ON WELL TO THE SYRINGE, CUSTOMER NOT EXACTLY SURE WHAT THE ISSUE IS. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. NUMBER OF OCCURRENCES: 1. ITEM NUMBER . CHOOSE ONE: 3 ML SYRINGE ¿ 309657, 26 G, 3/8¿ NEEDLE ¿ 305110. PRODUCT LOT NUMBER: 8222973. 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 USED A DIFFERENT NEEDLE AND COMPLETED LOAD SUCCESSFULLY WITHOUT ISSUES. NOTE: PRODUCT CATEGORY = NEEDLE/SYRINGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409765 SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 8222973 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Other