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

Catalog Number	D10057
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.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 the patient underwent a caesarean section and suture was used.The needle was detached from the suture easily during use.It was a control release needle.There were no adverse consequences to the patient.No further information is available at this time.
Additional Manufacturer Narrative
Device evaluation summary: representative sample was returned for analysis.The sutures were dispensed without problems and examined along of the strand and no defects were observed.The sample was visually and functionally examined for needle pull strength and they met the requirements.

• 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: 7433720
• Report Number: 2210968-2018-72150
• Device Sequence Number: 1314929
• Product Code: NEW
• UDI-Device Identifier: 10705031134324
• UDI-Public: 10705031134324
• 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,Followup
• Report Date (Section B): 03/24/2018

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: 12/31/2022
• Device Catalogue Number: D10057
• Device Lot Number: MAM832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Initial Date Received by Manufacturer: 03/24/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 04/16/2018
• Supplement Report FDA Received Date: 05/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1