BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 11069179 · Received December 23, 2020

    Report

    Report Number
    1024879-2020-00950
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    August 7, 2020
    Report Date
    January 25, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    K991088
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELD WAS UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER CONTAINED FOREIGN MATTER AND THERE WAS A BREAK DURING USE. "YOU WILL FIND ATTACHED THE MATERIAL VIGILANCE DECLARATIONS MADE ON AUGUST 4/2020 (A-2020-065) AND OCTOBER 16/2020 (A-2020-088) AS WELL AS THE PHOTO OF THE DEVICE INVOLVED IN THE AUGUST MATERIAL VIGILANCE A-2020-65. ONLY THE SAMPLE OF THE AUGUST MATERIAL VIGILANCE HAS BEEN KEPT. IT IS AVAILABLE FOR ANALYSIS. I DO NOT KNOW WHAT THE LIQUID IN THE SAMPLE CORRESPONDS TO. THE AUGUST MATERIAL VIGILANCE DECLARATION (A-2020-065) WAS SENT BY FAX TO (B)(6) ON 07/08/2020 AT 16:38. FOR THE OCTOBER MATERIAL VIGILANCE DECLARATION, I DO NOT KNOW BY WHAT MEANS IT WAS MADE, IT WAS THE FORMER INTERN WHO HAD SENT IT. DATE OF THE INCIDENT: (B)(6) 2020 WHILE USING THE VACUTAINER ADAPTER, IT BROKE IN THE NURSE'S HANDS. CONSEQUENCES FOR THE PATIENT: NONE WHAT HAPPENED IN THE UNIT: NUCLEAR MEDICINE THE DEVICE HAS BEEN RETAINED. THE INCIDENT IS ISOLATED THERE WILL BE NO ANSM DECLARATION. CONTAMINATION OF THE SAMPLE UNKNOWN." H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES, BUT 6 PHOTOS WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR BROKEN LUER ADAPTER WITH THE INCIDENT LOT WAS OBSERVED. THE PHOTOS ALSO SHOW THAT THE LUER ADAPTER DEVICE WAS ATTACHED TO WHAT APPEARS TO BE SOME SORT OF DEVICE NOT MANUFACTURED BY BD CONTAINING A LIQUID IN IT. 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. AS PER THE PRODUCT LABELING BD RECOMMENDS THE FOLLOWING, ¿NOT FOR USE WITH INDWELLING CATHETERS/PORTS; USE A BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE INSTEAD.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER CONTAINED FOREIGN MATTER AND THERE WAS A BREAK DURING USE. "YOU WILL FIND ATTACHED THE MATERIAL VIGILANCE DECLARATIONS MADE ON AUGUST 4/2020 (A-2020-065) AND OCTOBER 16/2020 (A-2020-088) AS WELL AS THE PHOTO OF THE DEVICE INVOLVED IN THE AUGUST MATERIAL VIGILANCE A-2020-65. ONLY THE SAMPLE OF THE AUGUST MATERIAL VIGILANCE HAS BEEN KEPT. IT IS AVAILABLE FOR ANALYSIS. I DO NOT KNOW WHAT THE LIQUID IN THE SAMPLE CORRESPONDS TO. THE AUGUST MATERIAL VIGILANCE DECLARATION (A-2020-065) WAS SENT BY FAX TO (B)(6) ON 07/08/2020 AT 16:38. FOR THE OCTOBER MATERIAL VIGILANCE DECLARATION, I DO NOT KNOW BY WHAT MEANS IT WAS MADE, IT WAS THE FORMER INTERN WHO HAD SENT IT. DATE OF THE INCIDENT: (B)(6) 2020 WHILE USING THE VACUTAINER ADAPTER, IT BROKE IN THE NURSE'S HANDS. CONSEQUENCES FOR THE PATIENT: NONE WHAT HAPPENED IN THE UNIT: NUCLEAR MEDICINE THE DEVICE HAS BEEN RETAINED. THE INCIDENT IS ISOLATED THERE WILL BE NO ANSM DECLARATION. CONTAMINATION OF THE SAMPLE UNKNOWN."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER CONTAINED FOREIGN MATTER. "YOU WILL FIND THE MATERIAL VIGILANCE DECLARATIONS MADE ON (B)(6) 2020 (B)(4) AND (B)(6) 2020 (B)(4) AS WELL AS THE PHOTO OF THE DEVICE INVOLVED IN THE (B)(4) MATERIAL VIGILANCE (B)(4). ONLY THE SAMPLE OF THE (B)(6) MATERIAL VIGILANCE HAS BEEN KEPT. IT IS AVAILABLE FOR ANALYSIS. I DO NOT KNOW WHAT THE LIQUID IN THE SAMPLE CORRESPONDS TO. THE (B)(6) MATERIAL VIGILANCE DECLARATION (B)(4) WAS SENT BY FAX TO (B)(6) ON (B)(6) 2020 AT 16:38. FOR THE (B)(6) MATERIAL VIGILANCE DECLARATION, I DO NOT KNOW BY WHAT MEANS IT WAS MADE, IT WAS THE FORMER INTERN WHO HAD SENT IT. DATE OF THE INCIDENT: (B)(6) 2020. WHILE USING THE VACUTAINER ADAPTER, IT BROKE IN THE NURSE'S HANDS. CONSEQUENCES FOR THE PATIENT: NONE WHAT HAPPENED IN THE UNIT: NUCLEAR MEDICINE. THE DEVICE HAS BEEN RETAINED. THE INCIDENT IS ISOLATED. THERE WILL BE NO ANSM DECLARATION. CONTAMINATION OF THE SAMPLE UNKNOWN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1530637 BD VACUTAINER MULTIPLE SAMPLE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 0057559

    Patients

    Seq Age Sex Outcome Treatment
    1