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

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/14/2022

Event Type  Injury  

Event Description

It was reported a patient underwent a laparoscopic gastrectomy on (b)(6) 2022 and a drain was used.The drain was placed under the left diaphragm and fixed outside the body through a port wound in the upper left abdomen.One week later, in the ward, it was found that the drain was cut off in the body surface part.The drain inside the abdominal cavity was in the body and could not be removed, thus emergency reoperation was performed.When checked using a laparoscope, a stump of the drain was found in the abdominal wall, so it was removed and wound was closed, and reoperation was completed.Further details are not provided.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).(b)(4).Additional information received: product code : 2232 or 2230.Additional information has been requested and received.Attempts have been made to obtain the device, however not received to date.If further details are received at a later date a supplemental medwatch will be sent.Were there any intra-operative complications? if so, what were they? no further information is available.Where was the tip of drainage tube located? bottom of the left diaphragm.How was the drain secured? no further information is available.What was the date of first activation? a week before the event date was the drain functioning /patent? no further information is available.How was the product function verified following the first activation? no further information is available.Who monitored the drainage and how often? no further information is available.Were any anomalies noted of the drain condition upon placement? no further information is available.Did the drain come in contact with sharp objects at any time: surgical instruments, surgical needles, sutures,? no further information is available.Was the drain cut with an instrument? no further information is available.Was the drain broken? there was a broken piece of the drain in the abdominal wall.What is the physician¿s opinion as to the etiology of or contributing factors to this event? no further information is available.What is the patient's current status? no further information is available.Surgeon¿s name? lot number? no further information is available.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure 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.

Manufacturer Narrative

Product complaint # (b)(4).H3 evaluation: the product was returned for evaluation.Drain sample was received in two pieces of 220mm and 770mm, actual size of drain dispatched was 1200mm.Drain was cut before the fluted area which is likely to happen due to sharp object used during surgery, thereby external factors like improper handling, improper usage at user end could not be ruled out.Further investigation of the sample was not possible.As the drain was functional for 1 week as stated in the complaint statement, no manufacturing related defect was observed.Lot number unknown, retain sample could not be checked.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon, or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: BLAKE DRAIN UNKNOWN PRODUCT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): DEGANIA INDIA; 251, sector-6, imt manesar; gurugram ; IN
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 14852510
• MDR Text Key: 294929119
• Report Number: 2210968-2022-04966
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention