MAUDE Adverse Event Report: ETHICON INC. PROLENE BLU 30IN 6-0 D/A BV-1 VB; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	EH7240H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being 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.The following additional information was obtained: how was case completed? new suture any adverse patient consequences and stating what medical/surgical intervention was provided to manage them.No device return status/ follow up as required.Representative samples to be returned.
Event or Problem Description
It was reported that the patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle of the suture came off.The procedure was completed with a like device.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot number mmq259-xneh7240, and no non-conformances were identified.Device evaluated by mfr: three unopened samples of product code eh7240, lot mmq259 were returned for analysis.During the visual inspection of three samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no pull off suture needle was found, and the tested samples met the finished goods requirements.

• Brand Name: PROLENE BLU 30IN 6-0 D/A BV-1 VB
• 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: 8518954
• Report Number: 2210968-2019-80399
• Device Sequence Number: 13914881
• Product Code: GAW
• UDI-Device Identifier: 10705031095618
• UDI-Public: 10705031095618
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K208091
• 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,Followup
• Report Date (Section B): 03/22/2019

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: 10/31/2023
• Device Catalogue Number: EH7240H
• Device Lot Number: MMQ259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 04/17/2019; 04/24/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 04/23/2019; 05/17/2019
• Patient Sequence Number: 1