MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 36IN 5-0 D/A V-5; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8934H
Medical Device Problem Codes	Defective Component (2292); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	05/09/2022
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.Photo analysis: pictures received.The first picture show one empty box of product code w8830, lot qabdpj.The second picture show one sealed overwrap packet product code 8934, lot qjbbra.According to visual inspection of the printing information on the box and overwrap package, the product code is different (w8830 and 8934), however, the information is correct, two product codes have the same characteristics type v -5 ½ circle taper cut 16mils.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as to what caused the reported complaint since the sample was not returned for analysis.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts have been made to retrieve the device.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.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2022 and suture was used.Doctor complained that after the change of product code from w8830 to 8934, product with new code is sharper than older code.He thinks 8934 is a tapercut needle rather than a cc needle.The needle only tears patient's vessel, there was no further operation required.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 9/12/2022.H6 component code: g07002 no device problem found.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional test evaluation were conducted on the returned device.No product for the code w8830 was received.Visual analysis of the returned sample revealed that one seal package of product code 8934h was returned for evaluation.Upon initial inspection of the sample, no external damages were observed.In order to evaluate the conditions of the returned sample, the packaging was opened.No defects were detected on the product; the swage and attachment area were noted to be as expected.The returned needles were noted to be the corresponding tapercut needle for the 8934h product code.No damages or needle deformation were observed during the visual inspection.The needles were passed through a tissue simulator and no abnormalities were noted.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.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 36IN 5-0 D/A V-5
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• 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 PR
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14626488
• Report Number: 2210968-2022-04357
• Device Sequence Number: 11921722
• Product Code: GAW
• UDI-Device Identifier: 10705031022058
• UDI-Public: 10705031022058
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,Followup
• Report Date (Section B): 09/12/2022

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 Expiration Date: 07/31/2025
• Device Model Number: 8934H
• Device Catalogue Number: 8934H
• Device Lot Number: QJBBRA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2020
• 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