MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 2X18IN 7-0 D/A BV175-8 EP; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number	EPM8746
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 coronary artery bypass graft procedure on an unknown date; and a suture was used.During the procedure, the needle detached from the suture during continuous suturing on the coronary artery though the surgeon used the needle-suture with the usual way and no tension was applied to it.It was not a control release needle.The operation time was extended within 30 minutes.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: PRLNE BLU 2X18IN 7-0 D/A BV175-8 EP
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10315613
• Report Number: 2210968-2020-05519
• Device Sequence Number: 11024143
• Product Code: GAW
• UDI-Device Identifier: 10705031203686
• UDI-Public: 10705031203686
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 07/13/2020

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 Model Number: EPM8746
• Device Catalogue Number: EPM8746
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 07/23/2020
• Patient Sequence Number: 1