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 Number: 2022
• MDR Report Key: 2022
• Date Received: 1993-01-05
• Date of Report: 1992-12-09
• Date of Event: 1992-12-02
• Date Facility Aware: 1992-12-02
• Report Date: 1992-12-09
• Date Reported to FDA: 1992-12-09
• Date Reported to Mfgr: 1992-12-08
• Date Added to Maude: 1993-01-06
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HICKMAN SUBCUTANEOUS PORT TITANIUM PORT
• Generic Name: 9.6 FRENCH PORT
• Product Code: LLD
• Date Received: 1993-01-05
• ID Number: 06-02230
• Device Availability: *
• Implant Flag: *
• Device Sequence No: 1
• Device Event Key: 1879
• Manufacturer: BARD DAVOL

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	1993-01-05