MAUDE Adverse Event Report: ETHICON INC. PDSII MONO VIO; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	D10058
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/20/2018
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.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.
Event or Problem Description
It was reported that a patient underwent a cesarean section procedure on (b)(6) 2018, and suture was used.The suture was used on dermis by interrupted suturing and the needle tip broke.The surgeon searched for the tip using fluoroscopy and the tip was not found.The procedure was extended within 30 minutes.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: PDSII MONO 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: 8257737
• Report Number: 2210968-2019-78469
• Device Sequence Number: 1923569
• Product Code: NEW
• UDI-Device Identifier: 10705031134331
• UDI-Public: 10705031134331
• 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): 12/25/2018

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 Expiration Date: 08/31/2023
• Device Catalogue Number: D10058
• Device Lot Number: MKK167
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/25/2018
• Initial Report FDA Received Date: 01/17/2019
• Patient Sequence Number: 1