MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 4X24IN 7-0 D/A BV-1 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPM8702
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a coronary artery bypass grafting procedure on (b)(6) 2022 and suture was used.The product was used for the blood vessel.The needle came off during use and fell into the body cavity.Although it took time, the needle was retrieved from the body.After the surgeon lost sight of the needle, the inside of the body cavity was checked, but the needle was not found, but then it was found outside the patient's body (it was found on the body).It was not a control release needle.No additional treatment was performed.After that, there was no problem with the patient's condition.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint#: (b)(4).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.Additional information was requested, and the following was obtained: was the needle retrieved during the same procedure? yes.The surgery was a coronary artery bypass grafting, and the product was used for the blood vessel.After the surgeon lost sight of the needle, the inside of the body cavity was checked, but the needle was not found, but then it was found outside the patient's body.(it was found on the body).No additional treatment was performed.After that, there was no problem with the patient's condition.The following information was requested, but unavailable: were x-rays taken to locate the needle? what measures were taken to retrieve the needle? was there any additional tissue damage as a result of searching for the needle? do you have any photos available for visual analysis? please provide the lot number: 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: PRLNE BLU 4X24IN 7-0 D/A BV-1 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15711403
• Report Number: 2210968-2022-09024
• Device Sequence Number: 12417522
• Product Code: GAW
• UDI-Device Identifier: 10705031134805
• UDI-Public: 10705031134805
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2022

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: EPM8702
• Device Catalogue Number: EPM8702
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 11/01/2022
• 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