HICKMAN SUBCUTANEOUS PORT TITANIUM PORT

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-05 for HICKMAN SUBCUTANEOUS PORT TITANIUM PORT manufactured by Bard Davol.

Event Text Entries

[1198] Patient is an oncology patient who had a hickman subcutaneous port inserted on 9/3/92. On 12/2/92 at 1:00 pm while she was at home in her kitchen, she noted that her heart rate was irregular. Her pulse 90 and irregular. She arrived in er at 1:40 pm - heart rate was 220. Unable to control rate with medication. An x-ray revealed infusa port fragment in inferior vena cava. Sheath fragment removed intact without dificulty. Patient doing well 12/3/92. Catheter removed. Patient has both partsdevice 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: material degradation/deterioration, telemetry failure, none or unknown, port. Conclusion: device failed during assembly, device failure directly caused event, none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: no data. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2022
MDR Report Key2022
Date Received1993-01-05
Date of Report1992-12-09
Date of Event1992-12-02
Date Facility Aware1992-12-02
Report Date1992-12-09
Date Reported to FDA1992-12-09
Date Reported to Mfgr1992-12-08
Date Added to Maude1993-01-06
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 NameHICKMAN SUBCUTANEOUS PORT TITANIUM PORT
Generic Name9.6 FRENCH PORT
Product CodeLLD
Date Received1993-01-05
ID Number06-02230
Device Availability*
Implant Flag*
Device Sequence No1
Device Event Key1879
ManufacturerBARD DAVOL


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 1993-01-05

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