MAUDE Adverse Event Report: ETHICON INC. POLYPROYLENE SUTURE; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	F1801
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.Upon opening the package of the device, the thread wasn't whole and has only one needle instead of length of 75cm and 2 needles.The device was not used on the patient.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Device evaluation summary: an empty labeled winding former and a dispensed needle/suture piece of product code f1801, lot # mph541 were returned for analysis.During the visual inspection of the sample, the swage and attachment area of the needle were noted to be as expected and the suture was observed detached due the stress applied to the strand, present damaged on the surface and stress at the end.A section of the strand was missing due to the strand was busted.This product code is double armed.According to sample condition, it could not be determined what may have caused the reported incident of: ¿at the opening of the blister of the device, the thread wasn't whole and has only one needle instead of a thread of 75cm and 2 needles¿.A manufacturing record review was performed for the finished device batch mph541 and no non-conformances were identified.

• Brand Name: POLYPROYLENE SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8541110
• Report Number: 2210968-2019-80622
• Device Sequence Number: 19447349
• Product Code: GAW
• UDI-Device Identifier: 10705031242081
• UDI-Public: 10705031242081
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133356
• 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): 03/27/2019

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: 11/30/2023
• Device Catalogue Number: F1801
• Device Lot Number: MPH541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2019
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/10/2019
• Patient Sequence Number: 1