PERMCATH PDLC5519

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-04-09 for PERMCATH PDLC5519 manufactured by Vas-cath, Inc..

Event Text Entries

[20055476] Perm catheter broke during hemodialysis with arterial hub of catheter seperating from remainder of perminate catheter causing blood loss and possible infectiondevice labeled for single use. Patient medical status prior to event: unknown. There was not multiple patient involvement. Invalid data - on device service/maintenance. No data - regarding date last serviced. Service provided by: invalid data. Invalid data - service records availability. No imminent hazard to public health claimed. Device used as labeled/intended. Device was evaluated after the event. Method of evaluation: visual examination. Results of evaluation: telemetry failure, hub. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, device returned to manufacturer/dealer/distributor. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number5441
MDR Report Key5441
Date Received1993-04-09
Date of Report1993-03-10
Date of Event1993-03-02
Date Facility Aware1993-03-02
Report Date1993-03-10
Date Reported to Mfgr1993-03-10
Date Added to Maude1993-07-13
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional0
Initial Report to FDA0
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NamePERMCATH
Generic NameHEMODIALYSIS CATHETER
Product CodeFJT
Date Received1993-04-09
Catalog NumberPDLC5519
Lot Number169-075
ID Number19CM, SOFT CELL
OperatorOTHER HEALTH CARE PROFESSIONAL
Device AvailabilityY
Implant FlagY
Device Sequence No1
Device Event Key5137
ManufacturerVAS-CATH, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1993-04-09

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