PORT-A-CATH 21-4030 69-4128 69-4228

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1992-07-27 for PORT-A-CATH 21-4030 69-4128 69-4228 manufactured by Pharmacia Deltec.

Event Text Entries

[459] 7/12/92 pt. Present as out patient for routine flusing of port-a-cath. Unit will not flush or aspirate. 7/13/92 pt. Seen by surgeon. Tubing has disconnected from porta cath and is located in pulmonary artery. 7/14/92 tubing removed in cath lab forsyth memorial hospital. 7/16/92 resvoir removed davie county hospital. Pt. Said dhe was told tubing had been off about 5 weeks from the fibrosis around it. Unit has been in since 1/9/90. 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: none or unknown. 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 Number: 1024
• MDR Report Key: 1024
• Date Received: 1992-07-27
• Date of Report: 1992-07-16
• Date Facility Aware: 1992-07-12
• Report Date: 1992-07-16
• Date Reported to FDA: 1992-07-16
• Date Reported to Mfgr: 1992-07-16
• Date Added to Maude: 1992-08-03
• 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-CATH
• Generic Name: VENOUS ACCESS DEVICE
• Product Code: LKG
• Date Received: 1992-07-27
• Model Number: 21-4030
• Catalog Number: 69-4128 69-4228
• Lot Number: 10820 12137
• Operator: OTHER
• Device Availability: Y
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 980
• Manufacturer: PHARMACIA DELTEC

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1992-07-27