PORT-A-CATH (SQUARE SHAPED DEVICE)

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-11-17 for PORT-A-CATH (SQUARE SHAPED DEVICE) manufactured by Unknown.

Event Text Entries

[1243] This patient came to hospital for retrieval of a portion of a port-a-cath catheter. The catheter was removed uneventfully and sent to the pathology department. The patient's husband has possession of the portion of the catheter. The date of port insertion is unknown as it was inserted at another facility. The brand of port-a-cath is not recognizableinvalid data - regarding single use labeling of device. Patient medical status prior to event: unknown. 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: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: yes. Corrective actions: device permanently removed from service, other. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1824
• MDR Report Key: 1824
• Date Received: 1992-11-17
• Date of Report: 1992-10-30
• Date of Event: 1992-10-09
• Date Facility Aware: 1992-10-09
• Report Date: 1992-10-30
• Date Reported to FDA: 1992-10-30
• Date Added to Maude: 1992-12-04
• 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

• Generic Name: PORT-A-CATH (SQUARE SHAPED DEVICE)
• Product Code: LKG
• Date Received: 1992-11-17
• Operator: OTHER
• Device Availability: N
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 1701
• Manufacturer: UNKNOWN

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-11-17