MAUDE Adverse Event Report: ETHICON INC. BLAKE (R) DRAIN 10FR ROUND; CATHETER, IRRIGATION

Model Number 2227

Device Problem Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 04/15/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date sent to the fda.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Attempts to obtain the following information has been performed and the following was received.If the further details are received at a later date a supplemental medwatch will be sent were there any unexpected outcomes or complications as a result of the prolonged surgery time? no.Was the patient treatment altered in anyway due to the prolonged surgery time? if yes, please explain the incision site was reopened, then another drain was placed.Leakage was found before leaving the operating room and before the patient woke up from anesthesia.What is the current condition of the patient? the patient is hospitalized, but there is no problem with patient's condition.Device return status we regularly contact with sales rep about the device returning.No further information will be provided.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.

Event Description

It was reported a patient underwent a laminectomy on (b)(6) 2020 and a drain was used.During surgery, after the drain was placed inside the dura mater, the incision site was closed.Then negative pressure was applied but drainage was not done.When checking the drain, it was found that exudate leakage occurred from the drain.The incision site was reopened, then another drain was placed during the initial procedure prior to patient leaving the operating room and before coming out of anesthesia.The operation time was extended within 30 minutes.The patient is currently hospitalized.Further details are not provided.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).H3 evaluation: received one used 10fr drain.There is the 3 mm long cut on the drain, between black dot and fluted part.Manufacturer production process includes 100% visual inspection of drains and it is highly unlikely that damaged drain would pass this inspection.The drain most probably was damaged during use.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.

Manufacturer Narrative

(b)(4).Date sent to the fda: 09/14/2020.

• Brand Name: BLAKE (R) DRAIN 10FR ROUND
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10018501
• MDR Text Key: 189776831
• Report Number: 2210968-2020-03685
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003552
• UDI-Public: 10705031003552
• 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: 04/15/2020

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: 2227
• Device Catalogue Number: 2227
• Device Lot Number: J1916942
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2020
• Initial Date Manufacturer Received: 04/15/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 06/17/2020; 08/17/2020
• Supplement Dates FDA Received: 06/24/2020; 09/14/2020
• Patient Sequence Number: 1