MAUDE Adverse Event Report: ETHICON INC. PDS II SUTURE 27"(70CM) 3-0 VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z305H
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during a veterinarian procedure on an unknown date, suture was used.It was reported that the suture pulled off of the needle during the procedure.There were no patient consequences.Another like product was used to complete the procedure.Additional information is not available.

• Brand Name: PDS II SUTURE 27"(70CM) 3-0 VIO
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• MDR Report Key: 7248429
• Report Number: 2210968-2018-70723
• Device Sequence Number: 13711157
• Product Code: NEW
• UDI-Device Identifier: 10705031060395
• UDI-Public: 10705031060395
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: N18331
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/29/2018

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: Z305H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1