MAUDE Adverse Event Report: ETHICON INC. PDS PLUS SUT 18IN(45CM) 4-0 CLR; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP507
Medical Device Problem Code	Component Incompatible (1108)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2018
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 a patient underwent an unknown plastic surgery on (b)(6) 2018 and suture was used.During the procedure, it was noted that the suture looked thicker than usual.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria was met prior to the release of this lot.Additional summary: it was reported appearance - cosmetic or color ¿ suture and assembly - incorrect component.A top foil and a dispensed needle/suture combination were returned for analysis.During the visual inspection of sample, the swage and attachment area were as expected.The suture was examined along of strand and no defects or unusual color were observed on the suture.Also, a functional test was performed on the sample using and the diameter met the requirements.No incorrect component was observed.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received, no appearance cosmetic or color ¿ suture or assembly - incorrect component were found.

• Brand Name: PDS PLUS SUT 18IN(45CM) 4-0 CLR
• 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: 7818289
• Report Number: 2210968-2018-75436
• Device Sequence Number: 2446479
• Product Code: NEW
• UDI-Device Identifier: 10705031048478
• UDI-Public: 10705031048478
• 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): 07/30/2018

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: 05/31/2020
• Device Model Number: PDP507
• Device Catalogue Number: PDP507G
• Device Lot Number: MGM679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Initial Date Received by Manufacturer: 07/30/2018
• Supplement Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 10/08/2018
• Patient Sequence Number: 1