BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 8752982 · Received July 2, 2019

    Report

    Report Number
    1024879-2019-01098
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 14, 2019
    Report Date
    August 7, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673440
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: INVESTIGATION SUMMARY: BD RECEIVED PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR A CUT IN THE TUBING WITH THE INCIDENT LOT WAS 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#764355 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR A CUT IN THE TUBING WITH THE INCIDENT LOT WAS OBSERVED. FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH CAPA#764355 AND THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES ARE BEING IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. ROOT CAUSE DESCRIPTION: CAPA#764355 WAS CONDUCTED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED THE MOST LIKELY ROOT CAUSES AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED. 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. THE INVESTIGATION HAS IDENTIFIED POTENTIAL ROOT CAUSE(S) FOR THIS ISSUE AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A HOLE IN TUBING WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET. THIS OCCURRED ON 3 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367344 BATCH NO. 8253781 IT WAS REPORTED THAT THERE WAS A TEAR/RIP/HOLE ON WINGSET LINE/TUBING. "TEAR IN WINGSET LINE. 21G GREEN BUTTERFLIES, LOT NUMBER 8253781 HAVE A RIP OR HOLE IN THE TUBING."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE TYPE: JKA, FPA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A HOLE IN TUBING WITH A BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET. THIS OCCURRED ON 3 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367344, BATCH NO. 8253781. IT WAS REPORTED THAT THERE WAS A TEAR/RIP/HOLE ON WINGSET LINE/TUBING. "TEAR IN WINGSET LINE. 21G GREEN BUTTERFLIES, LOT NUMBER 8253781 HAVE A RIP OR HOLE IN THE TUBING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548020 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET JKA BECTON, DICKINSON & CO., (BD) 8253781 50382903673440

    Patients

    Seq Age Sex Outcome Treatment
    1 Other