MAUDE Adverse Event Report: ETHICON INC. BLAKE SI DRAIN 7MM FLAT 3/4 FLUTED W/ 3/16IN TR; CATHETER, IRRIGATION

Model Number	2216
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Additional information has been requested and received.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Please clarify, did the event occurred over the same procedure? or were two drains found to be defective over 2 separate patient procedures? this happened in 2 products in a row over the same procedure.What is the lot number of each damaged drain? unk.Was the patient harmed while attempting to penetrate their skin? no further information is available.How was the case completed? no further information is available.Please perform and document the follow up attempt for product return.Please document the shipment tracking number in notes or rmao sections.The device has been received at sukagawa and will be shipped.Please clarify, were the faulty drains used on the patient (were the drains attempted to be placed over the patient)? yes.Please confirm there were no patient consequences? there were no adverse consequences to the patient.H3 evaluation: two complaint samples of trocars without drain were received for evaluation.During visual inspection, sharp edges of the trocars were found in bend condition.As per standard practice, there is no generation point of such defect during the production.Also, 100% inspection was carried out, visual, before and after packing of finished goods, prior to the product release.There was no scope at end to missed out such defect, at manufacturing / release stage.Batch manufacturing record review is not performed, as the lot no.Of the complaint is unknown.Retention sample is not checked, as the lot no.Of the complaint is unknown.During investigation of the complaint, batch manufacturing record and retained sample review could not performed, as the lot number of the complaint was unknown.It is suspected that, the sharp edge of the trocars might have came in contact badly with some external object used during surgery.And lead to the defect generation.External factors like mishandling or improper usage at user end could not be ruled out.Therefore, further investigation of the received samples is not possible, as these factors are out of dmd scope.Note: events reported on: mw# 2210968-2023-02716.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.
Event or Problem Description
It was reported, a patient underwent an unknown surgery on an unknown date, and a drain was used.During use, the tip of the trocar, which should have been sharp, had been bent and it was difficult to penetrate the skin.Further details are not provided.There were no adverse consequences to the patient.Upon receipt of sample and analysis the sharp edges of the trocars were found to be in bent condition.

• Brand Name: BLAKE SI DRAIN 7MM FLAT 3/4 FLUTED W/ 3/16IN TR
• Common Device Name: 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: 16736967
• Report Number: 2210968-2023-02715
• Device Sequence Number: 6597647
• Product Code: GBX
• UDI-Device Identifier: 10705031003521
• UDI-Public: 10705031003521
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: CL I EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2216
• Device Catalogue Number: 2216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown