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

Model Number 2227

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); Not Applicable (3189)

Event Date 12/23/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The following information has been requested but not 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.No further information available as reporter details have not been disclosed (confidential).Procedure name? what is the lot number of product? were any anomalies noted of the drain condition upon placement? did the drain come in contact with sharp objects at any time: surgical instruments, surgical needles, sutures,? did the drain function as intended? where was the tip of drainage tube located? how was drain secured? please provide patient demographic information: age, gender, weight, bmi at the time of the index procedure? what is the current status of the patient? what is the physician¿s opinion as to the etiology of or contributing factors of this event? is drain fragment removed from patient available to be returned for analysis? no further information available as reporter details have not been disclosed (confidential).

Event Description

It was reported a patient underwent an unknown procedure on (b)(6) 2019 and drain was used.Drain inserted right groin during initial procedure.On (b)(6) 2019, upon post operative drain removal, the tip was unknowingly retained in patients subcutaneous tissue.Patient returned on the (b)(6) 2020 to have tip removed.No further information available as reporter details have not been disclosed.Additional information has been requested.

• 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
• 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: 10673633
• MDR Text Key: 211251460
• Report Number: 2210968-2020-07949
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003552
• UDI-Public: 10705031003552
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2227
• Device Catalogue Number: 2227
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/24/2020
• 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