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

Model Number 0070440

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/16/2017

Event Type  malfunction  

Event Description

During breast reconstructive surgery, bard drain was inserted into patient's breast tissue.Md noted gap in drain at white to clear tubing.

Event Description

During breast reconstructive surgery, bard drain was inserted into patient's breast tissue.Md noted gap in drain at white to clear tubing.

• Brand Name: HUBLESS SILICONE FLAT DRAIN
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): C.R. BARD, INC.; 1211 mary magnan blvd.; madison GA 30650
• MDR Report Key: 6439183
• MDR Text Key: 71015983
• Report Number: 6439183
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2017,03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0070440
• Device Lot Number: NGYGO132
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2017
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR