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

Catalog Number	10X42
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device mj6696 batch number, 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.
Event or Problem Description
It was reported that the patient underwent a unknown procedure on (b)(6) 2019 and suture was used.The suture was detached from the needle when it was used to close esophageal hiatus.It was not a control release needle.Further details are not provided.There were no adverse consequences to the patient.

• Brand Name: EB EXC 5GRN/5WHT 30IN 2-0 D/A RB-1
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9490013
• Report Number: 2210968-2019-91075
• Device Sequence Number: 13805391
• Product Code: GAT
• UDI-Device Identifier: 10705031001275
• UDI-Public: 10705031001275
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K946173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/28/2019

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: 07/31/2023
• Device Catalogue Number: 10X42
• Device Lot Number: MJ6696
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 12/18/2019
• Patient Sequence Number: 1