BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q-SYTE¿ EXTENSION SET 15 CM (6 IN) 0.34 ML MICRO BORE

    MDR report key: 8597555 · Received May 9, 2019

    Report

    Report Number
    9610847-2019-00363
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 24, 2019
    Report Date
    June 14, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    30382903851028
    PMA / PMN Number
    K013621
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: RECEIVED 10 UNUSED UNITS IN SEALED PACKAGES FROM CATALOG NUMBER 385102, LOT NUMBER 8239956 AND FIVE UNUSED UNITS IN SEALED PACKAGES FROM CATALOG NUMBER 385102. LOT NUMBER 8173701. ALL COMPONENTS WITHIN WERE PRESENT. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR BOTH REPORTED LOTS AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. VISUAL/MICROSCOPIC EXAMINATION: NO DAMAGE WAS OBSERVED ON ANY OF THE COMPONENTS OF THE REPRESENTATIVE UNITS RECEIVED FOR EVALUATION. WATER LEAK TEST: THE TEST WAS PERFORMED WITH THE Q-SYTE ON THE ACTUATED AND THE UNACTUATED POSITIONS AND WITH AND WITHOUT THE EXTENSION SET. NO LEAKAGE WAS OBSERVED ON ANY OF THE TESTS PERFORMED. CONCLUSION(S): THE RETURNED REPRESENTATIVE UNIT DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED, AND THE FAILURE DESCRIBED IN THE EVENT DESCRIPTION COULD NOT BE REPLICATED AT THE LABORATORY. Q-SYTE PRODUCT QUALITY IS EVALUATED DURING THE MANUFACTURING PROCESS WITH PRESCRIBED VARIABLE AND ATTRIBUTES INSPECTIONS. THESE INSPECTIONS ARE PERFORMED BY OPERATORS TO ENSURE PROCESS CHANGES ARE IDENTIFIED. IF DEFECTS ARE OBSERVED, DISPOSITION OF THE PRODUCT, ROOT CAUSE AND CORRECTIVE ACTION ARE APPLIED ACCORDING TO THE QUALITY CONTROL PLAN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LOT 8239956 LEAKED AT THE SEPTUM AND LOT 8173701 LEAKED ALONG EDGE DURING COLLECTION WITH A BD Q-SYTE¿ EXTENSION SET 15 CM (6 IN) 0.34 ML MICRO BORE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT NO. 8239956: AFTER A BLOOD COLLECTION, THE BLOOD LEAKED ALONG THE SPLIT SEPTUM (IT SEEMED TO NOT BEEN CLOSED /ATTACHED PROPERLY). THE PRODUCT HAD NOT YET BEEN USED FOR THE ADMINISTRATION OF MEDICINES. THE EMERGENCY NURSES INJECT THEIR INFUSION WITHOUT GLOVES, BUT I HAVEN'T RECEIVED A REPORT OF EXPOSURE TO MUCOUS MEMBRANE. I HAVE 10 LOCKS OF THE SAME LOT NUMBER READY FOR INSPECTION. *LOT NO. 8173701: -THE Q-SYTE LEAKED WHEN BLOOD WAS COLLECTED (NOT ALONG THE SPLIT SEPTUM, BUT ALONG THE EDGES). -THE PRODUCT HAD NOT YET BEEN USED FOR THE ADMINISTRATION OF MEDICINES. -THE EMERGENCY NURSES INJECT THEIR INFUSION WITHOUT GLOVES, BUT I HAVEN'T RECEIVED A REPORT OF EXPOSURE TO MUCOUS MEMBRANE. - I HAVE 5 LOCKS OF THE SAME LOT NUMBER READY FOR INSPECTION.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8239956; MEDICAL DEVICE EXPIRATION DATE: 2023-06-30; DEVICE MANUFACTURE DATE: 2018-10-23; MEDICAL DEVICE LOT #: 8173701; MEDICAL DEVICE EXPIRATION DATE: 2021-12-31; DEVICE MANUFACTURE DATE: 2018-06-27." (B)(6). A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LOT 8239956 LEAKED AT THE SEPTUM AND LOT 8173701 LEAKED ALONG EDGE DURING COLLECTION WITH A BD Q-SYTE¿ EXTENSION SET 15 CM (6 IN) 0.34 ML MICRO BORE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LOT NO. 8239956: AFTER A BLOOD COLLECTION, THE BLOOD LEAKED ALONG THE SPLIT SEPTUM (IT SEEMED TO NOT BEEN CLOSED /ATTACHED PROPERLY). THE PRODUCT HAD NOT YET BEEN USED FOR THE ADMINISTRATION OF MEDICINES. THE EMERGENCY NURSES INJECT THEIR INFUSION WITHOUT GLOVES, BUT I HAVEN'T RECEIVED A REPORT OF EXPOSURE TO MUCOUS MEMBRANE. I HAVE 10 LOCKS OF THE SAME LOT NUMBER READY FOR INSPECTION. LOT NO. 8173701: THE Q-SYTE LEAKED WHEN BLOOD WAS COLLECTED (NOT ALONG THE SPLIT SEPTUM, BUT ALONG THE EDGES). THE PRODUCT HAD NOT YET BEEN USED FOR THE ADMINISTRATION OF MEDICINES. THE EMERGENCY NURSES INJECT THEIR INFUSION WITHOUT GLOVES, BUT I HAVEN'T RECEIVED A REPORT OF EXPOSURE TO MUCOUS MEMBRANE. I HAVE 5 LOCKS OF THE SAME LOT NUMBER READY FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387683 BD Q-SYTE¿ EXTENSION SET 15 CM (6 IN) 0.34 ML MICRO BORE INTRAVASCULAR ADMINISTRATION SET FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10 30382903851028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other