MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN HBLS 15 FR; CATHETER, IRRIGATION

Model Number 2233

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Additional information was requested and the following was obtained: did the issue occur during initial activation? no information.How long after activation did the reservoir fully inflate? no information.Was any exudate collected in the reservoir when found inflated? no information.Were all connections in the drainage system secured? no information.Was any cut/pinhole/damage identified on the reservoir/drain? no information.Was another reservoir used to complete the case? no information.Was the drain removed from the patient and a new drain inserted surgically? no information.Explain how was the case completed? no information.Lot number of the drain 2233 used? no information.No further information will be provided.

Event Description

It was reported that a patient underwent a uterine adnexal tumor resection on (b)(6) 2018, and a drain was placed.On (b)(6) 2018, negative pressure was applied to the reservoir, but the reservoir got swelled soon.There were no adverse consequences to the patient.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Evaluation: received one used 15fr drain.The drain was thoroughly inspected visually however no damage was observed which could be reason for swelling of the reservoir.Upon functional test (using reservoir) the drain functioned properly.

Manufacturer Narrative

Product complaint # (b)(4).

• Brand Name: BLAKE (R) DRAIN HBLS 15 FR
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8196041
• MDR Text Key: 131407904
• Report Number: 2210968-2018-78008
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003613
• UDI-Public: 10705031003613
• Combination Product (y/n): N
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2018

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: Health Professional
• Device Model Number: 2233
• Device Catalogue Number: 2233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Initial Date Manufacturer Received: 12/03/2018
• Initial Date FDA Received: 12/26/2018
• Supplement Dates Manufacturer Received: 01/10/2018; 08/17/2020
• Supplement Dates FDA Received: 02/06/2019; 09/09/2020
• Patient Sequence Number: 1