* 0070430

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-12-22 for * 0070430 manufactured by C.r. Bard, Inc.

Event Text Entries

[21083652] During jp drain removal, tip of drain fractured and was retained in patient. She required surgery the next morning to remove. There were sutures at skin level.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4390811
• MDR Report Key: 4390811
• Date Received: 2014-12-22
• Date of Report: 2014-12-22
• Date of Event: 2014-11-13
• Report Date: 2014-12-22
• Date Reported to FDA: 2014-12-22
• Date Reported to Mfgr: 2015-01-07
• Date Added to Maude: 2015-01-07
• 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: 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: *
• Generic Name: DRAIN
• Product Code: GYC
• Date Received: 2014-12-22
• Model Number: *
• Catalog Number: 0070430
• Lot Number: *
• ID Number: *
• Operator: OTHER
• Device Availability: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: C.R. BARD, INC
• Manufacturer Address: 730 CENTRAL AVE. MURRAY HILL, NJ 07974 US 07974

Patients

Patient Number	Treatment	Outcome	Date
1	0		2014-12-22