MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 3-0 D/A SH + PLGT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	DC588
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/20/2025.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.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.One folder packet with a needle suture combination outside of the open overwrap packet that pertains to product code dc588.Upon initial inspection of the returned sample, it was noted that folder packet has been removed from the overwrap.In further investigation it was observed that the folder packet had become caught in the sealing area, compromised by the integrity of the package.Also, this condition likely caused difficulted to remove the folder.Based on the information currently available, open seal was identified during the investigation of the sample received.This product issue will be addressed through the ethicon quality system.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.
Event or Problem Description
It was reported that a patient underwent an unknown cardiovascular procedure on an unknown date and suture was used.During an unknown cardiovascular surgery, the contents were pressed against the outer (the sterile package) sealing and could not take out when tried to take it out from the package during surgery.The product was not used because there was a possibility that sterilization failure occurred.This event was found before use.It was not a control release needle.Another product was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.

• Brand Name: PRLNE BLU 36IN 3-0 D/A SH + PLGT
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22853160
• Report Number: 2210968-2025-09558
• Device Sequence Number: 20946755
• Product Code: GAW
• UDI-Device Identifier: 10705031036604
• UDI-Public: (01)10705031036604(17)290228(10)UCMJXL
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2025

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: DC588
• Device Lot Number: UCMJXL
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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 Sex: Unknown