J.P. [T WOUND] DRAIN *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-04-19 for J.P. [T WOUND] DRAIN * manufactured by Cardinal [health Medical Products Services].

Event Text Entries

[16299249] Rn [registered nurse] met resistance when pulling pt's jp drain. Contacted attending physician to see pt. Sutures were cut and the m. D. [medical doctor] pulled on the drain. There was a pop and out came part of the drain. Kub [kidney ureter and bladder] showed retained drain. Returned to o. R [operating room] to have it removed. It was discovered in surgery that part of the drain may have been sewn, thus the resistance in initially pulling the drain.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 538564
• MDR Report Key: 538564
• Date Received: 2004-04-19
• Date of Report: 2003-12-01
• Date of Event: 2003-12-01
• Date Added to Maude: 2004-08-13
• 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: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• 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: J.P. [T WOUND] DRAIN
• Generic Name: DRAIN
• Product Code: FCN
• Date Received: 2004-04-19
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 527830
• Manufacturer: CARDINAL [HEALTH MEDICAL PRODUCTS SERVICES]
• Manufacturer Address: 1430 WAUKEGAN MCGAW PARK IL 600856787 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2004-04-19