MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 4X18IN 4-0 S/A X-1 CR; SUTURE, SURGICAL, ABSORBABLE

Model Number	D10057
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device ppmdsh batch number, and no non-conformance's were identified.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 cesarean section on (b)(6) 2020 and suture was used.During the procedure, the suture was detached from the needle unintendedly when tying a knot during dermostitch.It was a control release needle.It was commented that the biting of the suture might be not enough.There were no adverse patient consequences.No additional information was provided.

• Brand Name: PDSII VIO 4X18IN 4-0 S/A X-1 CR
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10091631
• Report Number: 2210968-2020-04147
• Device Sequence Number: 3881360
• 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
• Report Date (Section B): 05/19/2020

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: 11/30/2024
• Device Model Number: D10057
• Device Catalogue Number: D10057
• Device Lot Number: PPMDSH
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 05/27/2020
• Patient Sequence Number: 1