BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER SAFETY-LOK BLOOD COLLECTION SET

    MDR report key: 10819921 · Received November 10, 2020

    Report

    Report Number
    2243072-2020-01806
    Event Type
    Injury
    Date Received
    November 10, 2020
    Date of Event
    October 14, 2020
    Report Date
    January 22, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903672832
    PMA / PMN Number
    K991088
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION OBTAINED DURING INVESTIGATION: D.4 MEDICAL DEVICE CATALOG #: 367281. D.4. MEDICAL DEVICE EXPIRATION DATE: 2023-05-31.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: CONCOMITANT PRODUCTS: DEVICE AVAILABLE FOR EVAL YES, CONCOMITANT PRODUCTS: RETURNED TO MANUFACTURER ON: 2020-11-16. INVESTIGATION SUMMARY BD RECEIVED 200 SAMPLES AND 1 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR SLEEVE FALL OFF WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES ALONG WITH 50 RETENTION SAMPLES FROM BD INVENTORY, WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND NO ISSUES WERE OBSERVED RELATING TO SLEEVE FALL OFF AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFIY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET LEAKAGE OCCURRED AT NPE OF NEEDLE, THE SAFETY WAS DIFFICLUT TO ACTIVATE AND A NEEDLE STICK INJURY OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER EXPERIENCED A DEFECTIVE LOCKING MECHANISM, NEEDLE STICK AND NON-PATIENT NEEDLE LEAKING. SOME OF THE STAFF HAVE BEEN REPORTING TO ME THAT THE BD VACUTAINER SAFETY-LOK BUTTERFLY NEEDLE IS DEFECTED AT TIMES. I HAD AN EMPLOYEE SUFFER A NEEDLE STICK LAST WEEK BECAUSE SHE CLAIMED WHEN SHE ACTIVATED THE SAFETY ON THE NEEDLE, THE COVER LEFT PART OF THE NEEDLE EXPOSED. TODAY, I HAD SOME STAFF REPORTING TO ME THAT WHEN THEY ARE CHANGING TUBES OUT DURING THE BLOOD COLLECTION PROCESS, THE RUBBER COVERING OVER THE NEEDLE IS COMING OFF AND BLOOD GOES EVERYWHERE. THIS IS HAPPENING OFTEN. NOT SURE WHO I NEED TO REPORT THESE FINDINGS TO?? THE LOT NUMBER OF THE NEEDLE THAT DID NOT CLOSE ALL THE WAY IS OE0911, EXP DATE 05-31-2023. CAN YOU PASS THIS INFORMATION ON TO BD??

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING A BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET LEAKAGE OCCURRED AT NPE OF NEEDLE, THE SAFETY WAS DIFFICLUT TO ACTIVATE AND A NEEDLE STICK INJURY OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER EXPERIENCED A DEFECTIVE LOCKING MECHANISM, NEEDLE STICK AND NON-PATIENT NEEDLE LEAKING. SOME OF THE STAFF HAVE BEEN REPORTING TO ME THAT THE BD VACUTAINER SAFETY-LOK BUTTERFLY NEEDLE IS DEFECTED AT TIMES. I HAD AN EMPLOYEE SUFFER A NEEDLE STICK LAST WEEK BECAUSE SHE CLAIMED WHEN SHE ACTIVATED THE SAFETY ON THE NEEDLE, THE COVER LEFT PART OF THE NEEDLE EXPOSED. TODAY, I HAD SOME STAFF REPORTING TO ME THAT WHEN THEY ARE CHANGING TUBES OUT DURING THE BLOOD COLLECTION PROCESS, THE RUBBER COVERING OVER THE NEEDLE IS COMING OFF AND BLOOD GOES EVERYWHERE. THIS IS HAPPENING OFTEN. NOT SURE WHO I NEED TO REPORT THESE FINDINGS TO?? THE LOT NUMBER OF THE NEEDLE THAT DID NOT CLOSE ALL THE WAY IS OE0911 EXP DATE 05-31-2023. CAN YOU PASS THIS INFORMATION ON TO BD??

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET LEAKAGE OCCURRED AT NPE OF NEEDLE, THE SAFETY WAS DIFFICLUT TO ACTIVATE AND A NEEDLE STICK INJURY OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT IS REPORTED CUSTOMER EXPERIENCED A DEFECTIVE LOCKING MECHANISM, NEEDLE STICK AND NON-PATIENT NEEDLE LEAKING. SOME OF THE STAFF HAVE BEEN REPORTING TO ME THAT THE BD VACUTAINER SAFETY-LOK BUTTERFLY NEEDLE IS DEFECTED AT TIMES. I HAD AN EMPLOYEE SUFFER A NEEDLE STICK LAST WEEK BECAUSE SHE CLAIMED WHEN SHE ACTIVATED THE SAFETY ON THE NEEDLE, THE COVER LEFT PART OF THE NEEDLE EXPOSED. TODAY, I HAD SOME STAFF REPORTING TO ME THAT WHEN THEY ARE CHANGING TUBES OUT DURING THE BLOOD COLLECTION PROCESS, THE RUBBER COVERING OVER THE NEEDLE IS COMING OFF AND BLOOD GOES EVERYWHERE. THIS IS HAPPENING OFTEN. NOT SURE WHO I NEED TO REPORT THESE FINDINGS TO? THE LOT NUMBER OF THE NEEDLE THAT DID NOT CLOSE ALL THE WAY IS OE0911 EXP DATE 05-31-2023. CAN YOU PASS THIS INFORMATION ON TO BD?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281727 BD VACUTAINER SAFETY-LOK BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON 367283 OE0911 50382903672832

    Patients

    Seq Age Sex Outcome Treatment
    1 Other