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

Model Number 2233

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following information has been requested and 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.Type of gyn procedure? no further information is available.Date of procedure? no further information is available.Date of event? no further information is available.What medical and or surgical intervention was provided to address the issue intestine injury? no further information is available.Patient demographics: initials / id, age or date of birth; bmi no further information is available.Current patient status.No further information is available.Does the surgeon believe there was a deficiency with the device that caused the event? please explain.No further information is available.No further information will be provided.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported a patient underwent an unknown ob-gyn surgery on an unknown date and a drain was used.During surgery, when passing the trocar needle to the tissue, the trocar needle went into the small intestine and injured it.The lot number is unknown.Further details are not provided.No sample will be returned.Additional information has been requested.

• 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
• 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
• MDR Report Key: 10904368
• MDR Text Key: 218256871
• Report Number: 2210968-2020-09242
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003613
• UDI-Public: 10705031003613
• 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: 10/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2233
• Device Catalogue Number: 2233
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2020
• 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
• Patient Outcome(s): Required Intervention