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).Device evaluation summary: an empty labeled winding former, a detached needle and a dispensed suture piece of product code z149, lot # mgz580.Returned for analysis.During the visual inspection of detached needle, the swage and attachment area were noted to be as expected and marks on the body and edge needle that appear to be by use of a surgical instrument cold be observed.The suture was received dispensed,present body fluids and the suture ends were observed damaged (cut), this condition causes the separation of the needle from the suture.According to sample condition, the assignable cause of the performance pull off suture needle was an improper handling.In handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.To avoid this kind of damage, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.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 a cardiac procedure on (b)(6) 2019 and suture was used.The needle pulled off the suture during use.A different device was used to complete the procedure.There were no adverse patient consequences reported.No additional information is available.

• 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: 8668571
• Report Number: 2210968-2019-82373
• Device Sequence Number: 11254886
• 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 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2019
• 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