BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 19781288 · Received July 19, 2024

    Report

    Report Number
    1024879-2024-00644
    Event Type
    Malfunction
    Date Received
    July 19, 2024
    Date of Event
    June 20, 2024
    Report Date
    June 22, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903673421
    PMA / PMN Number
    K220212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: G.2. MEDICAL DEVICE TYPE: FPA INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 30 RETAIN SAMPLES WERE SUBJECTED TO RETRACTION LOCKOUT TESTING, AND NO ISSUES WERE OBSERVED RELATING TO RETRACTION ISSUE 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF RETRACTION ISSUE-DOES NOT RETRACT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE NEEDLE DID NOT RETRACT. THIS EVENT OCCURRED 2 TIMES. THERE WAS NO REPORT OF IMPACT TO THE PATIENT OR USER. FRI JUN 21 21:17:29 GMT 2024 - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR? NO IF YES¿ DATE AND TIME OF DEATH: N/A IF YES¿ DETAILED DEATH DESCRIPTION: N/A DID A SERIOUS INJURY OCCUR? NO IF YES¿DETAILED SERIOUS INJURY: N/A DID ERRONEOUS RESULTS OCCUR? NO IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): N/A DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? YES IF YES¿DETAILED HAZARD INCLUDING ANY MEDICAL INTERVENTION: PER CUSTOMER, NEEDLE DID NOT RETRACT. REQUESTING ADDITIONAL INFORMATION. (B)(6) : ON (B)(6) 2024 ,21:17:11 (GMT) -IF SALES FORCE PIR COMPLAINT, DATE EMAIL RECEIVED: ON (B)(6) 24 -CUSTOMER PROBLEM: CUSTOMER REPORTS TWO INCIDENCES WHERE NEEDLE FAILED TO RETRACT FOR CAT 367342 LOT 4008036. -STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: PER (B)(4), CUSTOMER REPORTS TWO INSTANCES OF THE NEEDLE NOT RETRACTING. FOLLOW UP EMAIL SENT TO CUSTOMER. -CUSTOMER LOCATION (COUNTRY): US -DID THE SPECIMEN(S) NEED TO BE RECOLLECTED? FOLLOW UP EMAIL SENT TO CUSTOMER. -DID EXPOSURE TO BLOOD/ BF OCCUR? FOLLOW UP EMAIL SENT TO CUSTOMER. -IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION? FOLLOW UP EMAIL SENT TO CUSTOMER. -NEXT STEPS (IF NECESSARY): DOCUMENT COMPLAINT. FOLLOW UP EMAIL SENT TO CUSTOMER. -RESOLUTION ACHIEVED (Y/N)? : N -QUANTITY RECEIVED AND QUANTITY AFFECTED: 2 PRODUCTS AFFECTED. -SHIPMENT METHOD (DIRECTLY OR VIA DISTRIBUTOR): FOLLOW UP EMAIL SENT TO CUSTOMER. -IF IT IS A DISTRIBUTOR OR DIRECTLY FROM BD¿ WHO IS IT? FOLLOW UP EMAIL SENT TO CUSTOMER. -PHOTOS OR RETURNS REQUESTED?: FOLLOW UP EMAIL SENT TO CUSTOMER. -FOLLOW UP REQUIRED (Y/N)?: Y FRI JUN 21 21:15:46 GMT 2024 - PATIENT FIELDS UPDATED: HAZARD, INJURY OR ERRONEOUS RESULTS? YES HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS DID A DEATH OCCUR? NO IF YES¿ DATE AND TIME OF DEATH: N/A IF YES¿ DETAILED DEATH DESCRIPTION: N/A DID A SERIOUS INJURY OCCUR? NO IF YES¿DETAILED SERIOUS INJURY: N/A DID ERRONEOUS RESULTS OCCUR? NO IF YES¿DETAILED ERRONEOUS RESULTS (INCLUDE # OF ERRORS AND TYPE): N/A DID ANY HAZARD OCCUR (E.G. EXPOSURE TO BLOOD/BODILY FLUID, NEEDLE/PROBE STICK, SAFETY ISSUE)? YES IF YES¿DETAILED HAZARD INCLUDING ANY MEDICAL INTERVENTION: PER CUSTOMER, NEEDLE DID NOT RETRACT. REQUESTING ADDITIONAL INFORMATION. SERVICE MAX BATCH : 2024-06-20 20:39:24 (GMT) NULL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1552030 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 4008036 00382903673421

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown