DUAL LUMEN GROSHONG #60313 UNKNOWN

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-03 for DUAL LUMEN GROSHONG #60313 UNKNOWN manufactured by Bard Access Systems.

Event Text Entries

[4850] Groshong catheter was removed and replaced on 9/29/93 after leadage was noted from both ports; a pathology report indicates 0. 2 cm laceration was noted 13 cm distal to the proximal end of the catheter. Patient developed small pneumothorax which was noted after replacement of catheter. Device 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: other. Conclusion: device failure occurred and was related to event. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number7689
MDR Report Key7689
Date Received1994-01-03
Date of Report1993-10-04
Date of Event1993-09-29
Date Facility Aware1993-09-29
Report Date1993-10-04
Date Reported to Mfgr1993-09-29
Date Added to Maude1994-05-09
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 NameDUAL LUMEN GROSHONG #60313
Generic NameDUAL LUMEN CENTRAL CATHETER
Product CodeGBP
Date Received1994-01-03
Model NumberUNKNOWN
Catalog NumberUNKNOWN
Lot Number36BC4209
ID NumberUNKNOWN
Device AvailabilityY
Implant FlagY
Device Sequence No1
Device Event Key7368
ManufacturerBARD ACCESS SYSTEMS


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1994-01-03

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.