BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 7948134 · Received October 9, 2018

    Report

    Report Number
    3006948883-2018-00235
    Event Type
    Malfunction
    Date Received
    October 9, 2018
    Date of Event
    September 12, 2018
    Report Date
    November 15, 2018
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    UDI-DI
    00382903839148
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 3RD RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF LEAK FROM TOP OF SEPTUM (Q-SYTE) WITH LOT #7234455 REGARDING ITEM #383914. DHR REVIEW; WAS PREVIOUSLY CONDUCTED FOR THE SUB-ASSEMBLY LOTS (P/N 8004149) FOR INVESTIGATION (PR547538-587747 CR), WHICH DISCLOSED THE FOLLOWING: LOT 7212778: A TOTAL OF 216,000 UNITS WERE BUILT ON QFA LINE 4, FROM 4AUG17 THROUGH 5AUG17. LOT 7227585: A TOTAL OF 180,000 UNITS WERE BUILT ON QFA LINE 4, FROM 22AUG17 THROUGH 24AUG17 ALL CHALLENGE, SET-UP AND IN-PROCESS SAMPLES WERE PERFORMED PER QUALITY CONTROL PLAN AND ALL PASSED PER SPECIFICATIONS. NO QUALITY RELATED ISSUES WERE FOUND. THERE WERE NO REJECT ACTIVITY FINDINGS RELEVANT TO THE REPORTED DEFECT ASSOCIATED WITH THE SUB-ASSEMBLY LOT NUMBERS FOR THIS INCIDENT. NO QUALITY NOTIFICATIONS WERE INITIATED FOR THESE SUB-ASSEMBLY LOTS. THE PEURA (END USER RISK ANALYSIS) WAS ANALYZED TO DETERMINE THE RISK TO CUSTOMER. THE ANALYSIS SHOWED THAT DUE TO LOW OCCURRENCE, CURRENT RISK IS ACCEPTABLE. UNIT 1: NO OBSERVATION AND/OR TESTING COULD BE CONDUCTED AS A Q-SYTE FOR THIS ASSEMBLY WAS NOT RETURNED. UNIT 2: OBSERVATION AND TESTING WERE CONDUCTED ON THE Q-SYTE VISUAL EVALUATION: THE Q-SYTE HAD TRACES OF DRIED MEDIA/MEDS PRESENT. THERE WERE NO ANOMALIES OR DAMAGE TO THE EXTERNAL AREAS OF THE Q-SYTE UNIT; TOP BODY OR BOTTOM BODY (POLYCARBONATE). MICROSCOPIC EVALUATION: OBSERVED THE SLIT AT THE SEPTUM TOP DISK WAS CENTERED IN ITS CORRECT POSITION ON AND THERE WAS NO DAMAGE. THERE WERE NO TEARS (COLUMN TEAR) OR DAMAGE TO THE COLUMN WALL. LEAKAGE DID NOT OCCUR FROM ANY AREA OF THE UNIT WHEN LEAK TESTED IN BOTH THE UN-ACTUATED AND ACTUATED POSITIONS. OBSERVED THE SLIT AT THE SEPTUM BOTTOM DISK WAS CENTERED IN ITS¿ CORRECT POSITION AND THERE WAS A SMALL TEAR AT EACH END OF THE SLIT. A DEFINITE SOURCE THAT CONTRIBUTED TO THE TEAR(S) AT THE END OF THE SLIT OF THE SEPTUM BOTTOM DISK COULD NOT BE ESTABLISHED. THIS TYPE OF DAMAGE IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS AND/OR EXTRANEOUS FORCE. A FORMAL CORRECTIVE ACTION HAS NOT BEEN INITIATED AT THIS TIME. CUSTOMER COMPLAINT TRENDS ARE EVALUATED ON A MONTHLY BASIS. IF THE TREND OF A SPECIFIC TYPE OF COMPLAINT WARRANTS A FORMAL CORRECTIVE ACTION, RESOURCES WILL BE ASSIGNED AT THAT TIME. 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 A BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM HAD LEAKAGE AT THE Q-SYTE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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 A BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM HAD LEAKAGE AT THE Q-SYTE. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786621 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 7234455 00382903839148

    Patients

    Seq Age Sex Outcome Treatment
    1 Other