BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE

    MDR report key: 14342180 · Received May 9, 2022

    Report

    Report Number
    2243072-2022-00654
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Date of Event
    April 7, 2022
    Report Date
    May 24, 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

    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 AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED WHEN USING THE BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE THE PLUNGER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN PREPARING THE ARTERIAL BLOOD COLLECTION ANALYSIS FOR THE PATIENT, IT WAS FOUND THAT THE PISTON OF THE BLOOD COLLECTION DEVICE WAS ABNORMAL AND BLOOD COULD NOT BE EXTRACTED." D2: MEDICAL DEVICE BRAND NAME: BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE. D4: CATALOG # 364314. D4: MEDICAL DEVICE LOT #: 1208449. D4: MEDICAL DEVICE EXPIRATION DATE: 2023-08-31. D4: UDI # (B)(4). G.5. PMA / 510(K)#: K022426. H4: DEVICE MANUFACTURE DATE: 2021-07-27. H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 10 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR DEFORMED PLUNGER STOPPER WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF DEFORMED PLUNGER STOPPER 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 DEFORMED PLUNGER STOPPER. BD DETERMINED THAT THE ROOT CAUSE OF THE INDICATED FAILURE MODE WAS ATTRIBUTED TO WORN MANUFACTURING EQUIPMENT AS WELL AS INTERFERING PARTS WITHIN THE MANUFACTURING PROCESS. SEVERAL CORRECTIVE ACTIONS ARE BEING PUT IN PLACE WHICH INCLUDE REPOSITIONING EQUIPMENT AND REPLACING WORN PARTS. THE PROCESS WILL CONTINUE TO BE REVIEWED AFTER CORRECTIVE ACTIONS HAVE BEEN COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE UNSPECIFIED BD PISTON SYRINGE THE PLUNGER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN PREPARING THE ARTERIAL BLOOD COLLECTION ANALYSIS FOR THE PATIENT, IT WAS FOUND THAT THE PISTON OF THE BLOOD COLLECTION DEVICE WAS ABNORMAL AND BLOOD COULD NOT BE EXTRACTED."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE THE PLUNGER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "WHEN PREPARING THE ARTERIAL BLOOD COLLECTION ANALYSIS FOR THE PATIENT, IT WAS FOUND THAT THE PISTON OF THE BLOOD COLLECTION DEVICE WAS ABNORMAL AND BLOOD COULD NOT BE EXTRACTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409831 BD PRESET¿ ARTERIAL BLOOD COLLECTION SYRINGE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 1208449

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown