MAUDE Adverse Event Report: ETHICON INC. SFX SYM PDS+ UNI VIO 18IN 0 S/A CTX; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	SXPP1A402
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot pbk800, 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 a c-section procedure on (b)(6) 2019 and a barbed suture was used.During the closure of the fascial layer of tissue, the suture began to dethread from the needle and then the needle popped off.A second like suture was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: SFX SYM PDS+ UNI VIO 18IN 0 S/A CTX
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9305708
• Report Number: 2210968-2019-89800
• Device Sequence Number: 1864738
• Product Code: NEW
• UDI-Device Identifier: 10705031218741
• UDI-Public: 10705031218741
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K113004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2019

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: 01/31/2021
• Device Catalogue Number: SXPP1A402
• Device Lot Number: PBK800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/20/2019
• Initial Report FDA Received Date: 11/11/2019
• Patient Sequence Number: 1