MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X24IN 8-0 D/A BV130-5 EP; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	EPM8739
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 was requested, and the following was obtained: * have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).>this is the first time i have reported this type of product complaint at this facility.* what are the procedure name(s) and date(s)? > procedures have been cabg (cardiac arterial bypass graft).Dates unknown.What is the quantity involved per procedure unknown, but at least once per procedure.* was there any adverse patient consequence(s) or subsequent medical/surgical intervention? > none reported.Unknown how far into each strand the needle popped off.Since this suture is typically used in a continuous baseball stitch manner, i do not know whether the needle separated at initiation or further into the closure after multiple manipulations by the surgeon.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned a review of the batch manufacturing records was conducted, and no related non-conformances were identified.The single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Related events captured via: 2210968-2024-05409 2210968-2024-05408 2210968-2024-05407 2210968-2024-05406.
Event or Problem Description
It was reported that the patient underwent a coronary artery bypass graft surgery on an unknown date and suture was used.On multiple occasions, the needle "popped off" from the suture, requiring another to be opened.When asked how many times, the nurse believed there were less than 12, but could not be more specific.Two boxes of the same lot number were involved.There was no patient harm.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/13/2024.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.

• Brand Name: PRLNE BLU 2X24IN 8-0 D/A BV130-5 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 19341660
• Report Number: 2210968-2024-05408
• Device Sequence Number: 15288714
• Product Code: GAW
• UDI-Device Identifier: 10705031218932
• UDI-Public: (01)10705031218932(11)231205(17)281130(10)TPMBST
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: EPM8739
• Device Lot Number: TPMBST
• 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: 04/22/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 05/17/2024
• Supplement Report FDA Received Date: 08/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2023
• 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