BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 7938790 · Received October 5, 2018

    Report

    Report Number
    3006948883-2018-00209
    Event Type
    Malfunction
    Date Received
    October 5, 2018
    Date of Event
    September 12, 2018
    Report Date
    November 15, 2018
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    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 · 0

    INVESTIGATION SUMMARY: DHR REVIEW; 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. RECEIVED ONE24GA PEGASUS ASSEMBLY WITHOUT PACKAGING. THE UNIT CONSISTED OF THE PEGASUS CATHETER/ADAPTER AND EXTENSION LINE ASSEMBLIES. THERE WAS A CAP ON ONE PORT AND A Q-SYTE AT THE SECOND PORT OF THE DUAL LUER ADAPTER. UNIT: OBSERVATION AND TESTING WERE CONDUCTED ON THE Q-SYTE VISUAL/MICROSCOPIC EXAMINATION (METHOD-N/A): VISUAL EVALUATION: 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. THERE WAS ONE SMALL TEAR AT ONE END OF THE SLIT. SEPTUM COLUMN TEAR ASSESSMENT (METHOD-QCPA-13): THERE WERE NO TEARS (COLUMN TEAR) OR DAMAGE TO THE COLUMN WALL. WATER LEAK TEST FOR ACTUATED AND UN-ACTUATED Q-SYTE (METHOD- MM-110): LEAKAGE DID NOT OCCUR FROM ANY AREA OF THE UNIT WHEN LEAK TESTED IN BOTH THE UN-ACTUATED AND ACTUATED POSITIONS. BOTTOM SEPTUM EVALUATION (METHOD-QCPA-13): CUT UNIT TO OBTAIN VIEW OF BOTTOM SEPTUM. OBSERVED THE SLIT AT THE SEPTUM BOTTOM DISK WAS CENTERED IN ITS¿ CORRECT POSITION AND THERE WAS A SMALL TEAR AT ONE END OF THE SLIT. NO OTHER ANOMALIES OR DAMAGE WAS OBSERVED. NOTE: THE FINDINGS IN THIS INCIDENT WERE INDICATIVE THAT THERE WAS NO PHYSICAL/MECHANICAL EVIDENCE TO CONFIRM OR SUPPORT MANUFACTURING PROCESS FOR THE ALLEGED FAILURE STATED IN THE PIR. CONCLUSION(S): INDETERMINATE: A DEFINITE SOURCE THAT CONTRIBUTED TO THE TEAR(S) AT THE END OF THE SLIT OF THE SEPTUM TOP AND BOTTOM DISK COULD NOT BE ESTABLISHED. THIS TYPE OF DAMAGE IS NORMALLY ATTRIBUTED TO INCORRECT USAGE OR EXCESSIVE ACTUATIONS AND/OR EXTRANEOUS FORCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WAS LEAKING. THERE WAS NO REPORT OF EXPOSURE, 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 THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WAS LEAKING. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778340 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 7234455

    Patients

    Seq Age Sex Outcome Treatment
    1 Other