MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 6-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8889H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.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.The following information was requested, but unavailable: confirm the specific number of devices (total qty actually involved with reported issue) that failed during this one event report/procedure for the reported lot?.
Event or Problem Description
It was reported that the patient underwent an unknown vascular procedure on (b)(6) 2019 and suture was used.The suture broke during use.It is unknown what was used to complete the procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 09/19/2019.A manufacturing record evaluation was performed for the finished device lot number pbr514 -c003z, and no non-conformances were identified.Additional h3 investigation summary: a picture of the sample was received for analysis.Upon visual inspection of the picture, a foreign matter than appears to be a fiber could be observed inside of the package.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Additional h3 investigation summary: an unopened sample of product code c003d, lot # pbr514 was returned for evaluation.During the visual inspection of an unopened sample, a foreign matter (fibers) that appear to be suture were observed into the overwrap packet.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to sample condition the assignable cause is a foreign matter into the packet.

• Brand Name: PROLENE SUTURE 30"(75CM) 6-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8693130
• Report Number: 2210968-2019-82684
• Device Sequence Number: 16629734
• Product Code: GAW
• UDI-Device Identifier: 10705031021754
• UDI-Public: 10705031021754
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 08/31/2023
• Device Catalogue Number: 8889H
• Device Lot Number: MKH809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 06/12/2019
• Supplement Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1