MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN 10MM FLAT 3/4 FLUTED W/ 3/16IN TR; CATHETER, IRRIGATION

Model Number 2217

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Event Description

It was reported a patient underwent an unknown surgery on (b)(6) 2022 and a drain was used.However, the drain was cut off at the insertion site.Fortunately, the product remained under the skin, so it was removed under local anesthesia.Further details are not provided.Additional information has been requested.

Manufacturer Narrative

Product complaint #: (b)(4).Additional information: component code: (b)(6).Additional information provided: it is unknown if the lot number - j2147307- is the correct lot number.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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).Additional information: d9.Additional information has been requested and the following was received.If further details are received at a later date a supplemental medwatch will be sent.No, this is not a duplicate.Procedure name? no further information is available.Was the drain ¿cut¿ or ¿broken¿? broken.Were there any intra-operative complications? if so, what were they? no further information is available.Where was the tip of drainage tube located? no further information is available.Was there any anomalies or damage to the drain noted during placement? no further information is available.How was the drain secured? under local anesthesia.What was the date of first activation? (b)(6) 2022.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.Was another product used? 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.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? dr.(b)(6).If applicable, will product be returned? if so, please provide the return date and tracking information.The device has been received at (b)(6) and will be shipped.Please check rmao.No further information will be provided.H3 evaluation: product sample received for analysis.One used sample of damaged drain with size around 50 mm, was received for evaluation during inspection ii was found that the drain was cut-off from the hub area which was likely happened 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 they are out of scope.The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 10MM FLAT 3/4 FLUTED 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 ; 9083863534
• MDR Report Key: 15739592
• MDR Text Key: 303146297
• Report Number: 2210968-2022-09172
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 10705031003538
• UDI-Public: 10705031003538
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 2217
• Device Catalogue Number: 2217
• Device Lot Number: J2147307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention