BLTPRT PLUS 5MM-12MM TRC W/BLTGRP 179075P

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2014-10-14 for BLTPRT PLUS 5MM-12MM TRC W/BLTGRP 179075P manufactured by Covidien.

Event Text Entries

[15999255] According to the reporter: a portion of the port broke off in the surgeon's hand.
Patient Sequence No: 1, Text Type: D, B5

[16064714] (b)(4).
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 9612501-2014-00358
• MDR Report Key: 4170626
• Report Source: 06
• Date Received: 2014-10-14
• Date of Report: 2014-10-08
• Date of Event: 2014-07-03
• Date Mfgr Received: 2014-10-08
• Date Added to Maude: 2014-10-27
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• 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: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: SHARON MURPHY
• Manufacturer Street: 60 MIDDLETOWN AVE
• Manufacturer City: NORTH HAVEN CT 06473
• Manufacturer Country: US
• Manufacturer Postal: 06473
• Manufacturer Phone: 2034925267
• Manufacturer G1: COVIDIEN
• Manufacturer Street: ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17
• Manufacturer City: SANTO DOMINGO
• Manufacturer Country: DR
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BLTPRT PLUS 5MM-12MM TRC W/BLTGRP
• Generic Name: DISPOSABLE SURGICAL ACCESS DEVICE
• Product Code: GDH
• Date Received: 2014-10-14
• Model Number: 179075P
• Catalog Number: 179075P
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: COVIDIEN
• Manufacturer Address: ZONA FRANCA DE SAN ISIDRO CARRETARA SAN ISIDRO KM17 SANTO DOMINGO DR

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-10-14