MAUDE Adverse Event Report: ETHICON INC. PDS LL PLUS ANTIBACTERIAL SUTURE; SUTURE, SURGICAL, ABSORBABLE

Catalog Number	PDP358T
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2018
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.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 during a c-section procedure on (b)(6) 2018 suture was used on a patient.While closing the tissue the needle popped off the suture.Another suture was opened, the needle popped off of the second suture as well.Both needles were recovered with no patient incident.Another like device was used to complete the procedure.There were no adverse consequences for the patient.No device will be returned.

• Brand Name: PDS LL PLUS ANTIBACTERIAL SUTURE
• 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: 7673425
• Report Number: 2210968-2018-74202
• Device Sequence Number: 13841524
• Product Code: NEW
• UDI-Device Identifier: 10705031048171
• UDI-Public: 10705031048171
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/13/2018

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: 09/30/2019
• Device Catalogue Number: PDP358T
• Device Lot Number: LLK392
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2018
• Initial Report FDA Received Date: 07/10/2018
• Patient Sequence Number: 1