BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES

    MDR report key: 8679937 · Received June 7, 2019

    Report

    Report Number
    1917413-2019-01580
    Event Type
    Malfunction
    Date Received
    June 7, 2019
    Date of Event
    May 16, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678865
    PMA / PMN Number
    K945952
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR UNDERFILLING WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR TESTING AND UPON COMPLETION, THE ISSUE RELATING TO UNDERFILL WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#260774. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR UNDERFILLING WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, TESTING OF THE RETAIN SAMPLES WAS CONDUCTED AND UNDERFILL WAS NOT OBSERVED. FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH CAPA#260774. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: CAPA#260774 HAS BEEN INITIATED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION IS CURRENTLY ON-GOING AND WILL BE UPDATED AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED. RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED.

    Description of Event or Problem · 0

    MATERIAL NO. 367886, BATCH NO. 8302834. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® LITHIUM HEPARIN (LH) 95 USP UNITS BLOOD COLLECTION TUBES THE TUBES WERE UNDER FILLING. THERE WERE TWO OCCURRENCES, BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CLIENT SAID THEY ARE HAVING ISSUES FILLING BLOOD TO THE TOP OF THE QTF 1 TUBE. SHE SAID THIS HAS HAPPENED TWO TIMES NOW¿ (IMPORTANT TO NOTE THAT THIS CLIENT REPORT THE ISSUE ALSO (B)(6) 2019, THESE ARE THE REPLACEMENT TUBES): THE LOT NUMBER: 8302834. EXPIRATION DATE OF THE TUBE: 03/31/2020.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EVALUATED BY MFR: A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 367886, BATCH NO. 8302834. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® LITHIUM HEPARIN (LH) 95 USP UNITS BLOOD COLLECTION TUBES THE TUBES WERE UNDER FILLING. THERE WERE TWO OCCURRENCES, BUT THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CLIENT SAID THEY ARE HAVING ISSUES FILLING BLOOD TO THE TOP OF THE QTF 1 TUBE. SHE SAID THIS HAS HAPPENED 2X TIMES NOW¿ (IMPORTANT TO NOTE THAT THIS CLIENT REPORTED THE ISSUE ALSO (B)(6) 2019. THESE ARE THE REPLACEMENT TUBES): THE LOT NUMBER: 8302834, EXPIRATION DATE OF THE TUBE: 03/31/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471075 BD VACUTAINER® LITHIUM HEPARINN (LH) 95 USP UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 8302834 50382903678865

    Patients

    Seq Age Sex Outcome Treatment
    1 Other