MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 30"(75CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8890H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch par864-8890h and no non-conformances were identified.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.
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 separated from the suture and fell into situs.It required some effort to retrieve the needle and delay in surgery.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 10/07/2019.Additional h3: it was reported a pull off - suture needle issue.One empty labeled winding former, a detached needle and a suture in two section of product code 8890, lot par864 were returned for analysis.During the visual inspection of the detached needle, the swage and attachment area were noted to be as expected.The barrel hole of the needle was examined under magnification and no suture remnant was noted and slightly marks were noted on the body of the needle.The suture pieces were examined, and the insertion end on one suture piece was observed to be as expected and the other extreme was cut.The ends other section of suture were cut.In addition, the force used to detach needle from the suture could not be determined.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, it could not be determined what may have caused the reported incident.One sealed box with unopened samples and unopened samples inside an opened box of product code 8890, lot par864 were returned for analysis.During the visual inspection of the 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.

• Brand Name: PROLENE SUTURE 30"(75CM) 5-0 BLU
• 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: 8976888
• Report Number: 2210968-2019-86768
• Device Sequence Number: 18897706
• Product Code: GAW
• UDI-Device Identifier: 10705031021785
• UDI-Public: 10705031021785
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 08/14/2019

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: 12/31/2023
• Device Catalogue Number: 8890H
• Device Lot Number: PAR864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 10/07/2019
• Patient Sequence Number: 1