MAUDE Adverse Event Report: ETHICON INC. PDSII VIO 30IN 6-0 D/A RB-2; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	Z149H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/30/2019
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.A manufacturing record evaluation was performed for the finished device mgz580 number, and no non-conformances were identified.
Event or Problem Description
It was reported that the patient underwent cardiac procedure on (b)(6) 2019 and suture was used.The needle pulled off from the suture during use.The fallen piece was retrieved from the patient.Another device was used to complete the procedure.There were no adverse patient consequences reported.No additional information could be provided.

• Brand Name: PDSII VIO 30IN 6-0 D/A RB-2
• 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: 8668157
• Report Number: 2210968-2019-82362
• Device Sequence Number: 2232338
• Product Code: NEW
• UDI-Device Identifier: 10705031060289
• UDI-Public: 10705031060289
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 05/08/2019

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: 05/31/2023
• Device Catalogue Number: Z149H
• Device Lot Number: MGZ580
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 06/04/2019
• Patient Sequence Number: 1