BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE 6 INCH EXT VLV

    MDR report key: 11803793 · Received May 10, 2021

    Report

    Report Number
    2243072-2021-01382
    Event Type
    Malfunction
    Date Received
    May 10, 2021
    Date of Event
    March 15, 2021
    Report Date
    September 2, 2021
    Product Code
    FPA
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE SMALLBORE 6 INCH EXT VLV EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FLUIDS WERE INFUSING VIA THE ALARIS PUMP WHEN THE TUBING BROKE." D2: MEDICAL DEVICE BRAND NAME: SMALLBORE 6 INCH EXT VLV D4: CATALOG # 20039E D4: MEDICAL DEVICE LOT #: 20125931 D4: MEDICAL DEVICE EXPIRATION DATE: 2023-12-11 D4: UDI # (B)(6) G.5. PMA / 510(K)#: K960280 H4: DEVICE MANUFACTURE DATE: 2020-12-07 D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-05-12 H6: INVESTIGATION SUMMARY A SAMPLE WAS RECEIVED AND TESTED BY OUR QUALITY TEAM. IT WAS IMMEDIATELY REALIZED THAT THIS SAMPLE WAS NOT THE SET DESCRIBED IN THE CUSTOMER'S COMPLAINT. THIS SET WAS AN INFUSION SET TO BE INSERTED IN A PUMP AND THERE WAS NO EVIDENCE OF SEPARATION THROUGHOUT THE SET. THE CUSTOMER'S COMPLAINT OF SEPARATION COULD NOT BE CONFIRMED AND THE ROOT CAUSE REMAINS UNKNOWN FOR THE 20039E SET. THE RECEIVED SET WAS THEN TESTED BY PRIMING WITH SALINE SOLUTION. THERE WAS A LEAKAGE JUST BELOW THE SAFETY CLAMP AT THE JUNCTION WHERE THE TUBING IS INSERTED INTO BLUE CLIP. THIS WAS ANALYZED USING A MICROSCOPE IN EFFORT TO DETERMINE THE ROOT CAUSE OF LEAKAGE. UNDER MAGNIFICATION, A CLEAR SHALLOW INSERTION WAS PRESENT IN THE BLUE CLIP WHERE THE TUBING IS SUPPOSED TO BE FULLY INSERTED. THIS IS THE ROOT CAUSE OF THE LEAK. THERE IS A RELATED COMPLAINT FROM THE CUSTOMER WITH A COMPLAINT OF LEAKAGE BUT THE LEAK IS REPORTED BELOW THE DRIP CHAMBER WHICH IS NOT WHERE THIS FAILURE OCCURRED. THE REASON FOR CUSTOMER SENDING IN A DIFFERENT SAMPLE THAN THE COMPLAINT REPORTED IS UNKNOWN. A DEVICE HISTORY RECORD REVIEW FOR MODEL 20039E LOT NUMBER 20125931 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4)UNITS IN 1 LOT NUMBER WAS BUILT ON 11DEC2020. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SMALLBORE 6 INCH EXT VLV EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FLUIDS WERE INFUSING VIA THE ALARIS PUMP WHEN THE TUBING BROKE."

    Additional Manufacturer Narrative · 1

    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. DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. INVESTIGATION CONCLUSION: MATERIAL NUMBER AND BATCH NUMBER IS UNKNOWN; REVIEWS COULD NOT BE PERFORMED. BASED ON LIMITED INFORMATION AVAILABLE AFTER MULTIPLE UNSUCCESSFUL ATTEMPTS TO OBTAIN - UNABLE TO ASSESS THE RM DOCUMENTATION. NO SAMPLE WAS PROVIDED BY THE CUSTOMER AFTER MULTIPLE REQUEST.  CAPA IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD INTRAVASCULAR ADMINISTRATION SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #: UNKNOWN BATCH/LOT #: UNKNOWN. FLUIDS WERE INFUSING VIA THE ALARIS PUMP WHEN THE TUBING BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698268 SMALLBORE 6 INCH EXT VLV INTRAVASCULAR ADMINISTRATION SET FPA 20125931

    Patients

    Seq Age Sex Outcome Treatment
    1