MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 24"(60CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	M8805
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Additional information was requested, and the following was obtained: was the foreign matter (hair) found within the sealed sterile package? yes.Procedure name and event date? open heart /(b)(6) 2021.When the event occurred? intra-op, pre-op or post-op? intra-op.Were there any patient consequences or adverse events? no/ it was requested that the box of suture be removed from the or and there are still two sterile un open suture packs left.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances related to the reported complaint condition were identified.
Event or Problem Description
It was reported that a patient underwent a heart procedure on (b)(6) 2021 and suture was used.Before use on the patient, it was reported by the distributor that a hair was found in the packaging.There were no patient consequences reported.Additional information was requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Date sent to the fda: 9/21/2021.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.H3 investigation summary: photo analysis: a visual analysis of a received image was performed and an open package was observed with a foreign matter that appears to be a hair inside the package.The product code is m8805.As part of our quality process, manufacturing records for this batch serial number were reviewed and 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 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.,according to the information received, it was reported by the distributor that hair was found in the pack.Device analysis: an opened sample of product m8805 was returned for evaluation.Upon visual analysis of the sample, a hair was observed stocked in the foam.It was not possible to determine the cause of the foreign matter in the sample received.Due to the conditions of the compliant device.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.As part of quality process, all devices are manufactured, inspected, and released to approved specifications.

• Brand Name: PROLENE SUTURE 24"(60CM) 6-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12363239
• Report Number: 2210968-2021-07646
• Device Sequence Number: 17077767
• Product Code: GAW
• UDI-Device Identifier: 10705031046238
• UDI-Public: 10705031046238
• Combination Product (Y/N): N
• 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: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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: 12/31/2025
• Device Model Number: M8805
• Device Catalogue Number: M8805
• Device Lot Number: RABDBA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2021
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1