MAUDE Adverse Event Report: ETHICON INC. BLAKE DRAIN UNKNOWN PRODUCT; CATHETER, IRRIGATION

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint #: (b)(4).Attempts to obtain the following information have been made and the following was received.To date the device has not been received.If the further details are received at a later date a supplemental medwatch will be sent.Can you please explain "air leakage occurred during use under the skin"? the drain was placed under the skin.The surgeon thought it occurred on the reservoir.Was the air leakage found in the drain? if no, please explain how was the reservoir used "under the skin"? please see the comment above.If the problem was with the drain, please provide product code and lot number.Did the reservoir function properly upon first activation? no further information is available.If yes, how long after the first activation happened did the issue occurred? did the drain or reservoir come in contact with surgical instruments, surgical needles, sutures, sharp objects at any time? no further information is available.How was the case completed? no further information is available.Was a second drain needed? no further information is available.Was a second reservoir needed? no further information is available.If a second drain or reservoir were needed, was a second surgery required to place any of the new devices? no further information is available.No further information will be provided.

Event Description

It was reported a patient underwent a pancreaticoduodenectomy on and unk and a drain was used.During surgery an air leakage occurred during use under the skin.Further details are not provided.No sample will be returned.There were no adverse consequences to the patient.Additional information has been requested.

• Brand Name: BLAKE DRAIN UNKNOWN PRODUCT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): DEGANIA SILICON LTD.-ISREAL; degania bet,; emek hayarden 15130 ; IS 15130
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10538471
• MDR Text Key: 207151852
• Report Number: 2210968-2020-06946
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: CL I EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/24/2020
• Initial Date FDA Received: 09/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1