COOK TPN 5FR DUAL LUMEN CATHETER C-TPN5-5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-29 for COOK TPN 5FR DUAL LUMEN CATHETER C-TPN5-5 manufactured by Cook, Inc..

Event Text Entries

[1751] Parents were bathing patient when the most distal end of the catheter at the "y" fell off. There was a clean break at the connector. Catheter was repaired with the appripriate kit by the surgeonsdevice labeled for single use. Patient medical status prior to event: satisfactory condition. 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: actual device involved in incident was evaluated, visual examination. Results of evaluation: mechanical problem, y-piece connector, tubing. Conclusion: device failure directly caused event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device repaired and put back in service. The device was not destroyed/disposed of.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2810
MDR Report Key2810
Date Received1993-01-29
Date of Report1992-09-03
Date of Event1992-08-20
Date Facility Aware1992-08-26
Report Date1992-09-03
Date Reported to FDA1992-09-03
Date Reported to Mfgr1992-09-02
Date Added to Maude1993-03-30
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 NameCOOK TPN 5FR DUAL LUMEN CATHETER
Generic NameDOUBLE LUMEN CENTRAL VENOUS CATHETER
Product CodeGBP
Date Received1993-01-29
Catalog NumberC-TPN5-5
Lot Number364286
OperatorOTHER CAREGIVERS
Device AvailabilityY
Implant FlagY
Device Sequence No1
Device Event Key2636
ManufacturerCOOK, INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1993-01-29

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