PORT-A-CATHE 21-4003

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-08-25 for PORT-A-CATHE 21-4003 manufactured by Pharmacia Deltec, Inc..

Event Text Entries

[686] The patient was admitted through the emergency room on august 1, 1992 with complaint of flank pain. Diagnostic work-up included a chestx-ray. The radiologist's interpretation identified "the distal 10. 5 cm of port-a-cath has broken off and is lodged in the left pulmonary artery. " the attending phtysician ordered interventional radiology to retreive the tubing. The tubing was retreived. The patient tolerated the proceduredevice 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: telemetry failure, other, unanticipated adverse reaction - short term, tubing. Conclusion: device failure directly caused 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 Number: 1208
• MDR Report Key: 1208
• Date Received: 1992-08-25
• Date of Report: 1992-08-11
• Date Facility Aware: 1992-08-02
• Report Date: 1992-08-11
• Date Reported to FDA: 1992-08-11
• Date Reported to Mfgr: 1992-08-11
• Date Added to Maude: 1992-09-02
• 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: PORT-A-CATHE
• Generic Name: N/A
• Product Code: LKG
• Date Received: 1992-08-25
• Model Number: 21-4003
• Catalog Number: 21-4003
• Lot Number: 17867
• ID Number: N/A
• Operator: OTHER
• Device Availability: Y
• Device Age: 01-JUN-91
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 1156
• Manufacturer: PHARMACIA DELTEC, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-08-25