BARD / DAVOL REF# 0070310 UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-11 for BARD / DAVOL REF# 0070310 UNK manufactured by C. R. Bard, Inc..

Event Text Entries

[89814882] Product had l3-s1 posterior segmental in stimulation and decompression procedure on (b)(6) 2017; a silicone round drain was placed, jp drain. On removal, in preparation for inpatient discharge, the nurse observed resistance felt stuck and then released. On removal inspection, an end of tube was jagged. Physician immediately notified. Ct confirmed soft tissue drainage catheter piece in laminectomy bed. Pt returned to surgery for retained device removal on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 6962365
• MDR Report Key: 6962365
• Date Received: 2017-10-11
• Date of Report: 2017-10-05
• Date of Event: 2017-09-27
• Date Facility Aware: 2017-09-27
• Report Date: 2017-10-05
• Date Reported to FDA: 2017-10-05
• Date Added to Maude: 2017-10-19
• 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: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: BARD / DAVOL
• Generic Name: SILICONE ROUND DRAIN - MEDIUM 1/8", 49" LONG
• Product Code: GBP
• Date Received: 2017-10-11
• Model Number: REF# 0070310
• Catalog Number: UNK
• Lot Number: UNK
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: NA
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: C. R. BARD, INC.
• Manufacturer Address: COVINGTON GA 30014 US 30014

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2017-10-11