MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X30IN 7-0 D/A BV175-8 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EPM8755
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4) d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.H6.Component code: g07002 - device not returned 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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.- was there any change in the patient¿s post-operative care due to the prolonged procedure? - was\were the needle piece(s) retrieved during the same procedure? - what measures were taken to retrieve the broken piece(s)? - was there any additional tissue damage as a result of searching for the needle piece(s)? - please provide the source or name and title of external person providing answers to follow-up (external person submitting answers to sales rep).- lot number? - name of procedure? 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 that a patient underwent an unknown procedure on an unknown date and a suture was used.During surgery, needle breakage (involved qty:1) and suture breakage (involved qty:2) occurred during sewing.Then ct was used to look for and remove the broken needle from patient.The surgery was delayed for more than 2 hours.The patient is currently stable.No adverse patient consequences were reported.Additional information was requested.
Additional 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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Corrected information: b3.Additional information: a2, a3a, d4 lot, d4 expiration date, d4 udi number, h4.Additional information was requested, and the following was obtained: event date should be (b)(6) 2025.Lot number should be 100qpc.After investigation, the patient, a 61-year-old male, underwent coronary artery bypass surgery in the (b)(6) on (b)(6) 2025.The operator used the suture ((b)(4)) for coronary artery anastomosis during surgery.During vascular anastomosis, one suture breakage and one problem of pulling off suture needle occurred for the same batch of sutures.After the problem of pulling off suture needle happened, the operator immediately gave the patient intraoperative ct examination to assist in finding and finding the detached needle.After removal, the integrity of the suture needle was checked.After confirming that there was no residual foreign body in the patient's body, a new suture (with unknown specific product information) was replaced for continuous suturing.The subsequent surgical operation went smoothly.The event prolonged the surgery for more than 2 hours (specific time was unknown), and the patient's current condition was stable.No subsequent adverse events were reported.The following information was requested but unavailable: - was there any change in the patient¿s post-operative care due to the prolonged procedure? - was there any additional tissue damage as a result of searching for the needle piece(s)? - please provide the source or name and title of external person providing answers to follow-up.
Additional 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 inc, or its employees that the report constitutes an admission that the product, ethicon inc 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.Additional information: h6.A manufacturing record evaluation was performed for the finished device, and no non-conformances were identified.Corrected info: d3 mfr email.

• Brand Name: PRLNE BLU 2X30IN 7-0 D/A BV175-8 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: 21293907
• Report Number: 2210968-2025-01219
• Device Sequence Number: 20729469
• Product Code: GAW
• UDI-Device Identifier: 10705031203709
• UDI-Public: (01)10705031203709(17)290331(10)100QPC
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

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 Catalogue Number: EPM8755
• Device Lot Number: 100QPC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2025
• Supplement Date Received by Manufacturer: 02/05/2025; 05/21/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/04/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2024
• 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 Age: 61 YR
• Patient Sex: Male