MAUDE Adverse Event Report: ETHICON INC. BLAKE 10MM FLAT FULL; CATHETER, IRRIGATION

Model Number	2214
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687); No Code Available (3191)
Date of Event	08/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).The following additional information has been requested, however not received to date: procedure name? were any anomalies noted of the drain condition upon placement? did the drain function as intended? 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? 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 or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2019 and a drain was used.On (b)(6) 2019 they went to remove the drain bedside and it snapped off.The drain was surgically removed on (b)(6) 2019.A new drain was not needed.The patient was discharged on (b)(6) 2019.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).Batch review has been completed of in-process and final packaging inspections as well as the manufacturing process with respect to the production batch.Batch # j1821456; mnf.Date 07-2018, exp.Date 07-2023.These products reported to be manufactured, inspected and packaged in conformance with customer specifications and have been found to be acceptable within all parameters.Investigation summary: it was received one used 2214 drain which is broken in its tube portion, 8 cm above the connection point with the white flat portion.There is nick on the broken end of the tubing.Since it was observed cut/nick on the broken end, it is concluded that, most probably, the drain broke following mechanical damage during use.Additional information was requested and the following was obtained: procedure name?: laparoscopic cholecystectomy, convert to open cholecystectomy.Were any anomalies noted of the drain condition upon placement?: no.Did the drain function as intended?: yes.Please provide patient demographic information: age, gender, weight, bmi at the time of the index procedure?: 58, m, 187lbs, 27.69 bmi.What is the current status of the patient?: healthy, well.Recovered.What is the physician¿s opinion as to the etiology of or contributing factors of this event?: unknown.Broke on removal at bedside.
Additional Manufacturer Narrative
(b)(4).Patient code: 3191 - surgical intervention.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/8/2020.Additional information: h6.Correction: d2, d2b, d3, g1, g2, g5.

• Brand Name: BLAKE 10MM FLAT FULL
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9246804
• Report Number: 2210968-2019-89142
• Device Sequence Number: 19612607
• Product Code: GBX
• UDI-Device Identifier: 10705031003507
• UDI-Public: 10705031003507
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: CL I EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/03/2023
• Device Model Number: 2214
• Device Catalogue Number: 2214
• Device Lot Number: J1821456
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2019
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 10/28/2019; 11/07/2019; 08/17/2020
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 11/06/2019; 11/20/2019; 09/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 85