MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 27"(70CM) 2-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D6659
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 ob-gyn procedure on an unknown date and suture was used.During port site closure, when ligaturing after the first passing of the needle through the tissue, the suture was broken other than the ligation part.There were no adverse consequences to the patient.

• Brand Name: PDS II SUTURE 27"(70CM) 2-0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8196595
• Report Number: 2210968-2018-78025
• Device Sequence Number: 1770835
• Product Code: NEW
• UDI-Device Identifier: 10705031026636
• UDI-Public: 10705031026636
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: N18331
• 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
• Report Date (Section B): 12/03/2018

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 Catalogue Number: D6659
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2018
• Initial Report FDA Received Date: 12/26/2018
• Patient Sequence Number: 1