MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Catalog Number	M8710
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The actual device batch number associated with this event is not known.The following are reported possible batch numbers: batch pah178 mfg date: 1/13/2019, exp date: 12/31/2023.Batch par913 mfg date: 1/10/2019, exp date: 12/31/2023.In addition, a manufacturing record evaluation was performed for the possible finished device lot numbers of pah178 and par913, 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.Additional information was requested and the following was obtained: when did the device issue occur? during handling (before use on patient) or actual suturing? unknown.Which lot was involved in this procedure pah178 or par913? as both were used it is unknown.Procedure name kit,thoracic outlet syndrome (o22b )207 how was case completed? unknown.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, the suture needle was releasing too quickly.It is unknown if another like device was used to complete the procedure.There were no adverse consequences for the patient.No additional information was provided.

• Brand Name: PROLENE SUTURE 30"(75CM) 5-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9224865
• Report Number: 2210968-2019-88974
• Device Sequence Number: 1892471
• Product Code: GAW
• UDI-Device Identifier: 10705031045842
• UDI-Public: 10705031045842
• Combination Product (Y/N): N
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2019

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 Catalogue Number: M8710
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2019
• Initial Report FDA Received Date: 10/23/2019
• Patient Sequence Number: 1