MAUDE Adverse Event Report: ETHICON INC. EB EXC 5GRN/5WHT 30IN 2-0 D/A RB-1; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	10X42
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot pem553, and no non-conformance 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.
Event or Problem Description
It was reported that a patient underwent a mitral valve repair on an unknown date and suture was used.During the procedure, the needle popped off of the suture when sewing in valve.It is unknown how the case was completed.No adverse patient consequences were reported.No additional information was provided.

• Brand Name: EB EXC 5GRN/5WHT 30IN 2-0 D/A RB-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9250634
• Report Number: 2210968-2019-89185
• Device Sequence Number: 19333514
• Product Code: GAT
• UDI-Device Identifier: 10705031001275
• UDI-Public: 10705031001275
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2019

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: 04/30/2024
• Device Catalogue Number: 10X42
• Device Lot Number: PEM553
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/02/2019
• Initial Report FDA Received Date: 10/29/2019
• Patient Sequence Number: 1