MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD UD 27IN 4-0 S/A RB-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	J214H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 03/06/2020.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 information was requested, but unavailable: what was used to complete the procedure? what tissue was being approximated or sutured when it broke?.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2020 and the suture was used.During surgery, the suture was broken during continuous suturing.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 04/07/2020.A manufacturing record evaluation was performed for the finished device le6382 batch number, and no non-conformances were identified.Investigation summary: it was reported breakage suture.One empty opened foil and one used suture of product code j214, lot le6382 was received for analysis.During the visual inspection of the opened sample, body fluids on the end cut that appears to be by the use of a surgical instrument could be observed.The needle was not returned for analysis.The functional test was performed and the tensile strength force was above the minimum requirement.As with any device, care should be taken to avoid damage to the strand when handling.Avoid the crushing or crimping action of the surgical instruments, such as needle holders and forceps.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Due to condition of the opened sample, the assignable cause of performance breakage suture suggests an improper handling by external cause.Unopened samples of product code j214, lot le6382 were 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 strand and no defects, damaged or suture breakage were observed.A functional test was performed and the tensile strength force was above the minimum requirement.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the representative samples, no performance - breakage suture was found and the tested samples met the finished goods requirements.

• Brand Name: VCL CT BRD UD 27IN 4-0 S/A RB-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9799553
• Report Number: 2210968-2020-01802
• Device Sequence Number: 779005
• Product Code: GAM
• UDI-Device Identifier: 10705031038226
• UDI-Public: 10705031038226
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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): 02/19/2020

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 Expiration Date: 04/30/2022
• Device Model Number: J214H
• Device Catalogue Number: J214H
• Device Lot Number: LE6382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/12/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 04/08/2020
• Patient Sequence Number: 1