BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD SYRINGE

    MDR report key: 8750788 · Received July 1, 2019

    Report

    Report Number
    2243072-2019-01300
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 11, 2019
    Report Date
    July 2, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    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

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTIONS: H.6. REASON CODE FOR NO EVALUATION: OTHER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UNSPECIFIED BD¿ SYRINGE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN IT WAS REPORTED THERE ARE BUBBLES AND LEAKAGE. 1. DESCRIPTION OF ISSUE: CONTACT REPORTED SHE WAS CHANGING CUSTOMER¿S CARTRIDGE, AND THE SYRINGE WOULD NOT GET RID OF AIR BUBBLES AND APPEARED TO HAVE A LEAK BETWEEN NEEDLE AND ORANGE PART OF NEEDLE. 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 3 ML SYRINGE ¿ 309657 5. PRODUCT LOT NUMBER: M213024 FROM BOX 6. FOR BD PRODUCT ONLY, ARE SAMPLES AVAILABLE FOR INVESTIGATION? 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? NO 9. RESOLUTION: CUSTOMER DECLINED BD FOLLOW UP FOR RETURNING PRODUCT. NO FURTHER FOLLOW UP IS REQUIRED. CTS TO SEND GOODWILL REPLACEMENT CARTRIDGES TO ENSURE CUSTOMER DOES NOT FALL SHORT IN SUPPLIES. CTS INSTRUCTED CUSTOMER TO CALL BACK IF ANY FURTHER ISSUES OCCUR. CUSTOMER UNDERSTOOD AND WAS SATISFIED. 10. NOTE: PRODUCT CATEGORY = NEEDLE/SYRINGE ISSUE

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED AS NO BATCH NUMBER WAS PROVIDED. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. RATIONALE: NO BATCH#/SAMPLE AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UNSPECIFIED BD¿ SYRINGE LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN IT WAS REPORTED THERE ARE BUBBLES AND LEAKAGE. DESCRIPTION OF ISSUE: CONTACT REPORTED SHE WAS CHANGING CUSTOMER¿S CARTRIDGE, AND THE SYRINGE WOULD NOT GET RID OF AIR BUBBLES AND APPEARED TO HAVE A LEAK BETWEEN NEEDLE AND ORANGE PART OF NEEDLE. DID THE CUSTOMER INSERT THE NEEDLE INTO THE CARTRIDGE AND ENCOUNTER FILL RESISTANCE? NO. PROCEED TO STEP 3. NUMBER OF OCCURRENCES: 1. ITEM NUMBER 3 ML SYRINGE ¿ 309657. PRODUCT LOT NUMBER: M213024 FROM BOX. 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? NO. RESOLUTION: CUSTOMER DECLINED BD FOLLOW UP FOR RETURNING PRODUCT. NO FURTHER FOLLOW UP IS REQUIRED. CTS TO SEND GOODWILL REPLACEMENT CARTRIDGES TO ENSURE CUSTOMER DOES NOT FALL SHORT IN SUPPLIES. CTS INSTRUCTED CUSTOMER TO CALL BACK IF ANY FURTHER ISSUES OCCUR. CUSTOMER UNDERSTOOD AND WAS SATISFIED. NOTE: PRODUCT CATEGORY = NEEDLE/SYRINGE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542426 UNSPECIFIED BD SYRINGE SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Other