SPIN-LOCK T-PORT EXTENSION SET ET-04TS

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1993-01-29 for SPIN-LOCK T-PORT EXTENSION SET ET-04TS manufactured by Burron Medical, Inc..

Event Text Entries

[1395] T-connector was connected to patient's iv and patient was receiving hyperalimentation with fat emulsion. Nurse noted blood backing up and saw leak at the light blue female connector which is cracked. Patient now has a (+) blood culture. This t-connector has been found cracked on three (3) other patients, same place on the connector. This was connected to either an arterial or venous catheter. These patients also subsequently developed (+) blood cultures. The items have been pulled form the stock and replacements being sought. One of the devices is available for inspection, and others have been discarded. Device labeled for single use. Patient medical status prior to event: critical condition. There was multiple patient involvement. Number of patients involved: 4. 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, mechanical tests performed, visual examination. Results of evaluation: design, hub, tubing. Conclusion: device failure indirectly caused event. Certainty of device as cause of or contributor to event: maybe. Corrective actions: device returned to manufacturer/dealer/distributor. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2803
• MDR Report Key: 2803
• Date Received: 1993-01-29
• Date of Report: 1992-11-04
• Date of Event: 1992-10-29
• Date Facility Aware: 1992-10-30
• Report Date: 1992-11-04
• Date Reported to FDA: 1992-11-04
• Date Reported to Mfgr: 1992-11-04
• Date Added to Maude: 1993-03-30
• 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: SPIN-LOCK T-PORT EXTENSION SET
• Generic Name: T-CONNECTOR
• Product Code: FKB
• Date Received: 1993-01-29
• Catalog Number: ET-04TS
• Lot Number: 439673 AND 444525
• Operator: OTHER HEALTH CARE PROFESSIONAL
• Device Availability: Y
• Device Age: 01-OCT-92
• Implant Flag: Y
• Device Sequence No: 1
• Device Event Key: 2629
• Manufacturer: BURRON MEDICAL, INC.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1993-01-29