MAUDE Adverse Event Report: C. R. BARD, INC. CHANNEL DRAIN, 10FR. ROUND HUBLESS FULL FLUTED WITH 3.2MM TROCAR; CATHETER, IRRIGATION

Model Number 072227

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 01/14/2021

Event Type  malfunction  

Event Description

Neurosurgeon attempting to place the drain in the surgical site and could not get the trocar to go through the skin as expected.Surgeon had to use excessive force and almost stuck himself trying.Another drain kit was retrieved and appears the same difficulty was encountered.

• Brand Name: CHANNEL DRAIN, 10FR. ROUND HUBLESS FULL FLUTED WITH 3.2MM TROCAR
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 11526384
• MDR Text Key: 241008110
• Report Number: 11526384
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 072227
• Device Catalogue Number: 072227
• Device Lot Number: NGEW4092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28105 DA
• Patient Weight: 69