MAUDE Adverse Event Report: C.R. BARD, INC. BARD DAVOL HUBLESS SILICONE FLAT DRAIN; CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY

Model Number 0070430

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 09/17/2018

Event Type  malfunction  

Event Description

Patient with head and neck melanoma underwent resection during which a 7mm jackson-pratt drain was placed.Approximately two weeks later, the drain was removed in clinic.The nurse practitioner who removed the drain noted, "drain suture was clipped and drain slid out.However, there was no white tip as expected with a jp drain.The drain did not have any resistance upon removal." the patient was taken to the outpatient operating room the following day for the removal of the retained tip of the drain.Upon inspection, it did not appear to have had a stitch placed through it.

Event Description

Patient with head and neck melanoma underwent resection during which a 7mm jackson-pratt drain was placed.Approximately two weeks later, the drain was removed in clinic.The nurse practitioner who removed the drain noted, "drain suture was clipped and drain slid out.However, there was no white tip as expected with a jp drain.The drain did not have any resistance upon removal." the patient was taken to the outpatient operating room the following day for the removal of the retained tip of the drain.Upon inspection, it did not appear to have had a stitch placed through it.

• Brand Name: BARD DAVOL HUBLESS SILICONE FLAT DRAIN
• Type of Device: CATHETER, VENTRICULAR, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): C.R. BARD, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 7959781
• MDR Text Key: 123544762
• Report Number: 7959781
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0070430
• Device Catalogue Number: 0070430
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/12/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 22265 DA
• Patient Weight: 39