MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN HBLS 15FR RND W/ 3/16IN TR; CATHETER, IRRIGATION

Model Number 2229

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/01/2022

Event Type  Injury  

Event Description

It was reported a patient underwent a breast reconstruction surgery on (b)(6) 2022 and a drain was used.Post op, in the ward/icu, when the drain was removed, the drain ruptured and a broken piece remained in the body.On (b)(6) 2022 the incision was made and the broken piece was removed from the body.The product was used on the subcutaneous.Further details are not provided.Additional information has been requested.

Manufacturer Narrative

Product complaint # (b)(4).[product use details] the sales rep will meet with the surgeon on (b)(6).However, at this point, the sales rep only knows that removing the drain was attempted on (b)(6), but the drain ruptured and a broken part remained in the body, hence a small incision was immediately made.Further details are not provided from the hp.When we send the sample to you, we will let you know its return date and tracking number.Additional information has been requested however not received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Date of procedure? were there any intra-operative complications? if so, what were they? where was the tip of drainage tube located? how was the drain secured? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? surgeon¿s name? product lot number? please provide the return date and tracking information.

Manufacturer Narrative

Product complaint # (b)(4).Additional information has been requested and received.Attempts to obtain the device have been made.If further details are received at a later date a supplemental medwatch will be sent.Date of procedure?=>before april 1.Detail is unknown.Were there any intra-operative complications? if so, what were they?=>additional incision.Where was the tip of drainage tube located? =>inside the patient's body.How was the drain secured?=>an additional small incision was made and the fragment was removed.What is the physician¿s opinion as to the etiology of or contributing factors to this event?=>dr.Said the drain was place as ¿j¿ shape, and the curved part of drain caused resistance against removal.What is the patient's current status?=>no problem.Surgeon¿s name?=>hirose taro product lot number?=>unknown.Please provide the return date and tracking information.=>the device has been received at sukagawa and will be shipped.Please check rmao.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.Product complaint # (b)(4).

Manufacturer Narrative

Product complaint # (b)(4).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.

Manufacturer Narrative

Product complaint # (b)(4).H3 evaluation: the product was returned for evaluation.One used sample of drain received for evaluation.Drain sample received in two parts.One part of size 140 mm and other part of drain found 860 mm.Actual size of drain is 1200 mm.Lot no.Of drain sample is unknown.Manufacturer is performing 100 % visual inspection before release of product.Defect can not be generated during our manufacturing process.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 SI DRAIN HBLS 15FR RND W/ 3/16IN TR
• 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
• MDR Report Key: 14272795
• MDR Text Key: 290674511
• Report Number: 2210968-2022-03220
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003576
• UDI-Public: 10705031003576
• 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,Followup,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2229
• Device Catalogue Number: 2229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2022
• 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
• Patient Sex: Female