MAUDE Adverse Event Report: ETHICON INC. PDS PLUS VIO 8X18IN 1 S/A CTXB CR; SUTURES - ABSORBABLE

Catalog Number	PDPB765D
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, 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 an unknown surgical procedure on (b)(6) 2019.During surgery, the surgeon felt that the suture was detached from the needle too easily during use.Another like device was used to complete the procedure.It was a control release needle.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Additional investigation summary: it was received for analysis an empty opened foil and a winding former with three undispensed needle/sutures in slot # 1 to 3 of product code pdpb765d, lot mmm925.The product code is control release and required eight strands per packet.During the visual inspection of the sample, the swage and attachment area were noted to be as expected.The suture was dispensed without problems and examined along of the strand and no defects, or damaged were observed.A functional test was performed and the pull force were above the minimum requirements.In addition, the needle and suture that failed was not received.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the conditions of the sample received, no pull off suture needle was found, and the tested sample met the finished goods requirements.

• Brand Name: PDS PLUS VIO 8X18IN 1 S/A CTXB CR
• Common Device Name: SUTURES - ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9240143
• Report Number: 2210968-2019-89057
• Device Sequence Number: 11154258
• Product Code: NEW
• UDI-Device Identifier: 10705031218901
• UDI-Public: 10705031218901
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• 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): 09/27/2019

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: 10/31/2020
• Device Catalogue Number: PDPB765D
• Device Lot Number: MMM925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Received by Manufacturer: 09/27/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 11/15/2019
• Patient Sequence Number: 1