BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 15582333 · Received October 11, 2022

    Report

    Report Number
    2243072-2022-01754
    Event Type
    Malfunction
    Date Received
    October 11, 2022
    Date of Event
    August 22, 2022
    Report Date
    October 18, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    K022426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTED INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING AN BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE THE GREEN CAP OF THE SPECIMEN FELL OFF AND BLOOD SPECIMEN SPILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE NURSE COLLECTED ARTERIAL BLOOD SAMPLES WITH BD ARTERIAL BLOOD COLLECTOR AND TRANSFERRED THEM TO THE LABORATORY DEPARTMENT WITH PNEUMATIC LOGISTICS BUCKET. AFTER RECEIVING A PHONE CALL FROM THE LABORATORY DEPARTMENT, THE GREEN CAP OF THE SPECIMEN FELL OFF AND THE BLOOD SPECIMEN SPILLED. BLOOD SAMPLES WERE REDRAWN AND SENT TO THE TEST WITHOUT ANY ADVERSE CONSEQUENCES." MDR OWNERSHIP LEGAL SITE NAME: BECTON, DICKINSON AND COMPANY (BD). D.2. MEDICAL DEVICE CATALOG#: 364314. D.2. MEDICAL DEVICE LOT#: 2041496. D.3. MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON AND COMPANY (BD). D.1. MEDICAL DEVICE BRAND NAME: BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE. D.4. MEDICAL DEVICE EXPIRATION DATE: 2024-02-29. D.5. UNIQUE IDENTIFIER (UDI) #:(B)(4). G.2. MANUFACTURING LOCATION: BECTON, DICKINSON AND COMPANY (BD). G.5. PMA/510(K)#: K022426. H.4. DEVICE MANUFACTURE DATE: 2021-12-09. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR LOOSE CAP CAUSING LEAKAGE WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH DRAWN WITH WATER AND END CAPS TIGHTENED, AND THE ISSUE OF LOOSE CAP CAUSING LEAKAGE WAS NOT OBSERVED. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE LOOSE CAP CAUSING LEAKAGE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. 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." UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN MANUFACTURER NAME, CITY AND STATE AND MFR SITE AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING AN BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE THE GREEN CAP OF THE SPECIMEN FELL OFF AND BLOOD SPECIMEN SPILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE NURSE COLLECTED ARTERIAL BLOOD SAMPLES WITH BD ARTERIAL BLOOD COLLECTOR AND TRANSFERRED THEM TO THE LABORATORY DEPARTMENT WITH PNEUMATIC LOGISTICS BUCKET. AFTER RECEIVING A PHONE CALL FROM THE LABORATORY DEPARTMENT, THE GREEN CAP OF THE SPECIMEN FELL OFF AND THE BLOOD SPECIMEN SPILLED. BLOOD SAMPLES WERE REDRAWN AND SENT TO THE TEST WITHOUT ANY ADVERSE CONSEQUENCES."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING AN UNKNOWN BD® BLOOD COLLECTION TUBES THE GREEN CAP OF THE SPECIMEN FELL OFF AND BLOOD SPECIMEN SPILLED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE NURSE COLLECTED ARTERIAL BLOOD SAMPLES WITH BD ARTERIAL BLOOD COLLECTOR AND TRANSFERRED THEM TO THE LABORATORY DEPARTMENT WITH PNEUMATIC LOGISTICS BUCKET. AFTER RECEIVING A PHONE CALL FROM THE LABORATORY DEPARTMENT, THE GREEN CAP OF THE SPECIMEN FELL OFF AND THE BLOOD SPECIMEN SPILLED. BLOOD SAMPLES WERE REDRAWN AND SENT TO THE TEST WITHOUT ANY ADVERSE CONSEQUENCES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360960 BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2041496

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown