MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 24IN 7-0 D/A CC EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EP8704H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch plj866, and no non-conformances were identified (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: - it was reported 6 needles involved, could you please confirm how many needles were disassembled at the moment to put the stitches? yes 6 needles of the mentioned product - when was the needle detached/pulled off from the suture (in the package, during removal from package, during handling or during use on the patient)? please specify during use on the patient 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 the patient treatment or post-operative care altered in anyway due to the prolonged surgery time of 20 minutes? was there any patient impact (ie.Additional treatment required) and/or adverse patient outcome due to the prolonged surgery? note: event reported in 2210968-2021-11976, 2210968-2021-11977, 2210968-2021-11978, 2210968-2021-11979, 2210968-2021-11980, and 2210968-2021-11981.
Event or Problem Description
It was reported that a patient underwent an cabg on (b)(6) 2021 and suture was used.During the procedure, at the moment to put the stitches, the needle is disassembled.The surgery was delayed by 20 minutes.Another like device was used to complete the procedure successfully.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: PRLNE BLU 24IN 7-0 D/A CC EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12864022
• Report Number: 2210968-2021-11976
• Device Sequence Number: 14559378
• Product Code: GAW
• UDI-Device Identifier: 10705031206779
• UDI-Public: 10705031206779
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/23/2021

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 Expiration Date: 09/30/2024
• Device Model Number: EP8704H
• Device Catalogue Number: EP8704H
• Device Lot Number: PLJ866
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2021
• Initial Report FDA Received Date: 11/23/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown