MAUDE Adverse Event Report: ETHICON INC. GUT PL UD 18IN 4-0 S/A SC-1; SUTURE, ABSORBABLE, NATURAL

Catalog Number	1824H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Evaluation: one opened box with eighteen unopened samples of product code 1824, lot mcm755 was received for analysis.During the visual inspection of thirteen 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 performance pull off suture needle was found, and the tested samples met the finished goods requirements and the reported complaint could not be replicated.If further details are received at a later date a supplemental medwatch will be sent.
Event or Problem Description
It was reported a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.The needle has pulled away from the suture and was in patient nose during procedure.They located the needle and removed it.No reported patient consequences.

• Brand Name: GUT PL UD 18IN 4-0 S/A SC-1
• Common Device Name: SUTURE, ABSORBABLE, NATURAL
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9173719
• Report Number: 2210968-2019-88521
• Device Sequence Number: 16759156
• Product Code: GAL
• UDI-Device Identifier: 10705031002654
• UDI-Public: 10705031002654
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K946173
• 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): 09/12/2019

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: 02/28/2023
• Device Catalogue Number: 1824H
• Device Lot Number: MCM755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 10/09/2019
• Patient Sequence Number: 1