MAUDE Adverse Event Report: ETHICON INC. ETHILON SUTURE 5"(13CM) 9-0 BLK; SUTURE, NONABSORBABLE, SYNTHETIC

Model Number 2819G

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2020

Event Type  malfunction  

Manufacturer Narrative

Product complaint: (b)(4).(b)(4).Attempts have been 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.Additional information was requested, and the following was obtained: what is the initial procedure? the issue has not been discovered during a procedure.When did the issue occurred? pre-op or intra-op? at the opening of the sample.Pre-op what is the event day and procedure date? early september.Could you please confirm device's availability? yes.

Event Description

It was reported that pre-op to unknown surgery in (b)(6) 2020 at the opening of sample, the needle does not match a correct one expected for the product code.There were no patient consequences reported.

Manufacturer Narrative

(b)(4).Date sent to the fda: 11/19/2020 additional information: d10, h4, h6 a manufacturing record evaluation was performed for the finished device batch qbbhdm, 2819g55 and no non-conformances were identified.Additional h3 investigation summary: a picture was received for evaluation.Upon to visual inspection of picture a overwrap packet, a folder and a dispensed needle/suture combination of product code 2819, lot # qbbhdm could be observed.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.No conclusion could be reached as on what caused the needle of the sutures from the lot qbbhdm does not match as the sample was returned for analysis.Additional h3 investigation summary: an empty opened overwrap packet, and empty opened folder and a dispensed needle/suture combination of product code 2819, lot # qbbhdm were received for evaluation.During the visual inspection of the sample, the closure of the channel needle was noted to be as expected, the needle was compared against the finish drawing rmc 5006161 (bv130-3 taper point 3/8 circle) and the results meet the ethicon requirements.The description for product code 2819g, ethilon monofilament black, suture diameter 9-0¿, length 5¿.The components were assigned correctly.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Additional h3 investigation summary: the needle of the sutures from the lot qbbhdm does not match with the correct one expected for the product code 2819g.A sealed sample of product code 2819, lot # qbbhdm was received for evaluation.During the visual inspection of sealed sample, no defects were found on the package.The sample was opened, and the closure of the channel needle was noted to be as expected, the needle was compared against the finish drawing rmc 5006161 (bv130-3 taper point 3/8 circle) and the results meet the ethicon requirements.The description for product code 2819g, ethilon monofilament black, suture diameter 9-0¿, length 5¿.The components were assigned correctly.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: ETHILON SUTURE 5"(13CM) 9-0 BLK
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10617513
• MDR Text Key: 209630986
• Report Number: 2210968-2020-07562
• Device Sequence Number: 1
• Product Code: GAR
• UDI-Device Identifier: 10705031004047
• UDI-Public: 10705031004047
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2819G
• Device Catalogue Number: 2819G
• Device Lot Number: QBBHDM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1