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

Catalog Number	8305H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 a cardiac operation on (b)(6) 2019 and a suture was used.It was reported that during surgery pull off suture needle occurred.A like device was used to complete surgery.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/31/2019.Additional investigation summary: it was received for analysis an empty opened labeled winding former, a needle/suture piece and detached needle of product code 8305, lot mlh086.During the visual inspection of two needles, the swage and attachment area were noted to be as expected.The barrel hole of the detached needle was examined under 20x magnification and no suture remnant was noted.The suture piece was examined, and the impression of the swage area could not be observed due the end was observed cut.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition it was suggest an improper handling of the sample.

• Brand Name: PROLENE SUT 24IN(60CM) 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: 9148167
• Report Number: 2210968-2019-88318
• Device Sequence Number: 2752778
• Product Code: GAW
• UDI-Device Identifier: 10705031014145
• UDI-Public: 10705031014145
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2019

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: 09/30/2023
• Device Catalogue Number: 8305H
• Device Lot Number: MLH086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Initial Date Received by Manufacturer: 09/09/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/02/2019
• Supplement Report FDA Received Date: 10/31/2019
• Patient Sequence Number: 1