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

Catalog Number	PDP507G
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 pulmonectomy procedure on (b)(6) 2018 and suture was used.The needle detached from the suture during continuous suturing.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.Investigation summary a labeled winding former with a needle inserted in a pink sponge was returned for analysis.During the visual inspection of the needle, the swage and attachment area were as expected.The barrel hole was examined under magnification for suture remnant and none was noted.The needle had a normal swaged.Slight marks on the body of the needle that appear to be by the use of a surgical instrument were observed.The suture was not returned to determine the assignable cause.Due to the sample condition, the assignable cause of the pull off could not be determined as the suture was not returned.

• 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: 7580271
• Report Number: 2210968-2018-73366
• Device Sequence Number: 16733028
• 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): 05/15/2018

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 Catalogue Number: PDP507G
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 06/15/2018
• Initial Report FDA Received Date: 06/07/2018
• Supplement Report FDA Received Date: 07/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1