BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 6902636 · Received September 28, 2017

    Report

    Report Number
    3006948883-2017-00070
    Event Type
    Malfunction
    Date Received
    September 28, 2017
    Date of Event
    September 4, 2017
    Report Date
    November 2, 2017
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). PMA / 510(K) #: THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. UDI #: (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: DHR REVIEW WAS PERFORMED ON THE SUB-ASSEMBLY LOT NUMBERS 6232865 AND 6244759 (MATERIAL # 8004149). PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED PER SPECIFICATIONS, IN ACCORDANCE WITH THE IN-PROCESS SAMPLING PLANS. PER REVIEW IT WAS NOTED THAT THERE WERE NO REJECT ACTIVITY FINDINGS THROUGHOUT THE BUILD OF THIS LOT THAT WOULD IMPACT UPON THE QUALITY OF THE PRODUCT. PER REVIEW OF THE DHR IT WAS CONCLUDED THAT ALL REQUIRED CHALLENGES SAMPLES AND TESTING WAS PERFORMED VISUAL ANALYSIS, OBSERVATIONS AND TESTING: RECEIVED A TOTAL OF 9 PEGASUS UNITS OF WHICH 8 OF THEM HAD A Q-SYTE CONNECTED TO THE / A PORT. VISUAL/MICROSCOPIC EVALUATION: SEPTUMS FOR UNITS 1, 2, 3, 5, 6 AND 7 WERE MOLDED USING THE 16 CAVITY MOLD. SEPTUMS FOR UNITS 4 AND 8 WERE MOLDED USING THE 32 CAVITY MOLD. ALL UNITS: CONNECTION WAS SECURE. NO DAMAGE WAS OBSERVED ON THE SEPTUM TOP DISK/SLIT. NO COLUMN DAMAGE WAS OBSERVED ON ANY OF THE SIDES OF THE COLUMN. NO DAMAGE WAS OBSERVED ON THE THREADS OF THE Q-SYTE UNIT (MALE LUER). NO DAMAGE WAS OBSERVED ON THE POLYCARBONATE MATERIAL FORMING THE Q-SYTE UNITS. ALL UNITS: ATTACHED THE ISO STANDARD LUER FROM THE WATER LEAK TEST TO THE END OF THE EXTENSION SET, NO LEAKAGE WAS OBSERVED IN EITHER THE ACTUATED OR THE UNACTUATED POSITIONS. ALL UNITS: BOTTOM SEPTUM REVEALED DAMAGED (TEARS) ON THE SLIT OF THE SEPTUM BOTTOM DISKS. INVESTIGATION SAMPLES(S) MEET MANUFACTURING SPECIFICATIONS: NO. CONCLUSIONS: THE DEFECT OF LEAKAGE COULD NOT BE CONFIRMED. NONE OF THE UNITS RECEIVED LEAKED OR HAD EVIDENCE / DAMAGE THAT COULD HAVE CAUSED THE UNITS TO LEAK. DID THE EVALUATION CONFIRM THE CUSTOMER¿S EXPERIENCE WITH THE BD PRODUCT? NO. THE CUSTOMER¿S EXPERIENCE COULD NOT BE CONFIRMED. THE UNITS WERE TESTED WITH AND WITHOUT EXTENSION SETS AND NO LEAKAGE WAS OBSERVED. WERE WE ABLE TO REPRODUCE THE CUSTOMER'S EXPERIENCE WITH THE BD PRODUCT? NO. THE DEFECT OF LEAKAGE EXPERIENCED BY THE CUSTOMER COULD NOT BE REPRODUCED WITH THE SAMPLES RECEIVED. ROOT CAUSE: RELATIONSHIP OF DEVICE TO THE REPORTED INCIDENT: INDETERMINATE. THE RETURNED UNITS DID NOT DISPLAY ANY ADVERSE CHARACTERISTICS THAT WOULD CONTRIBUTE TO THE DEFECT THE CUSTOMER EXPERIENCED. THE DEFECT DESCRIBED IN THE EVENT DESCRIPTION COULD NOT BE CONFIRMED OR REPLICATED. A DEFINITE CAUSE THAT CONTRIBUTED TO DAMAGE (TEARS) ON THE SEPTUM BOTTOM DISKS. THIS TYPE OF DAMAGE IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A NURSE THAT WHILE USING A BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM, LIQUID LEAKED FROM THE Q-SYTE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680078 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 6265053

    Patients

    Seq Age Sex Outcome Treatment
    1 Other