MAUDE Adverse Event Report: C.R. BARD, INC. HUBLESS SILICONE FLAT DRAIN; CATHETER, IRRIGATION

Catalog Number 0070440

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/21/2018

Event Type  Injury  

Event Description

When pulling a hubless silicone flat drain, the drain snapped at the connection between the drain and the collection tube.The patient returned to the operating room for retrieval of the drain fragment.

• Brand Name: HUBLESS SILICONE FLAT DRAIN
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): C.R. BARD, INC.; covington GA 30014
• MDR Report Key: 7995024
• MDR Text Key: 125144123
• Report Number: MW5080737
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0070440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR