MAUDE Adverse Event Report: ETHICON INC. VCL+ UD 36IN 0 S/A CT-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP945H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a c-section on (b)(6) 2022 and suture was used.When the suture was opened, the needle prematurely popped off near the end.Another like suture was used to complete the procedure.There were no adverse consequences for the patient.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.Additional information was requested and the following was received: were x-rays performed to localize the needle? - not needed because needle was removed was the needle removed from the patient? yes.Was the procedure completed successfully? yes.Lot number? not provided.What tissue was being approximated/ sutured? uterus.Device return status? the account does not have the product.Therefore, no product will be received.To date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare® active ingredient(s) ¿ triclosan dosage form ¿ suture/solid/parenteral strength ¿ = 275 g/m.Related events captured via 2210968-2022-04466.
Additional Manufacturer Narrative
(b)(4).Date sent to fda: 08/08/2022.This report is being submitted pursuant to the provisions of 21 cfr part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.Component code: g07002 ¿ device not returned.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: this complaint is for vcp945h, lot unknown.We received product return for vcp946h, lot number sa2acq.Was vcp946h, lot sa2acq involved in the complaint? was this product returned in error? will you be returning the product for vcp945h? this is a combination product, and the event has been reviewed for both the suture and the triclosan.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 275 g/m.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 8/25/2022.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.Additional information was requested, the following was obtained: we received product return for vcp946h, lot number sa2acq.Was vcp946h, lot sa2acq involved in the complaint? was this product returned in error? -the original complaint was reported based on the information the account reported to me.In following up with account, now they cannot confirm which sutures were submitted or involved.*returned product is pending analysis.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 275 g/m.
Additional Manufacturer Narrative
Product complaint (b)(4).Date sent to the fda: 9/12/2022.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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.H6 component code: g07002 no device problem found.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.H3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that it was received one needle and a suture that pertain to the product code vcp946h.During the visual inspection of the detached needle, the edge of the barrel hole could be observed with marks that appear by a surgical instrument and a suture piece was attached.The suture was examined, the end was cut, and body fluids were noted along of strand.Due to condition of the sample the functional test could not performed.The condition of the sample received indicate an improper handling of the device.To avoid this kind of damage: grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the attachment end to the point.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.Complaint information will be included in complaint trending that is reviewed on a regular basis to determine if further action is necessary.Additional h3 investigational summary: the product was returned to ethicon for evaluation.Visual inspection and functional testing were conducted on the returned device.Visual analysis of the returned sample determined that it was received one needle suture piece that pertain to the product code vcp946h.During the visual inspection of the detached needle, the swage and attachment area were noted to be as expected; no issues related to pull off suture needle was noted.The suture was examined, body fluids were found along of strand and the end was cut appears to be by use of surgical instrument.The product code contains an absorbable suture and the time of exposure that has the suture in the environment could not be determined; therefore, the functional test cannot be performed.As part of ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 275 ¿g/m.Related events captured via 2210968-2022-04466 and 2210968-2022-04467 product complaint (b)(4).Date sent to the fda: 9/12/2022.This is a combination product, and the event has been reviewed for both the suture and the triclosan.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, or its employees that the report constitutes an admission that the product, ethicon, 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: VCL+ UD 36IN 0 S/A CT-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN ANGELO; 3348 pulliam st; san angelo 76905 4403
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14654493
• Report Number: 2210968-2022-04467
• Device Sequence Number: 5109359
• Product Code: GAM
• UDI-Device Identifier: 10705031056145
• UDI-Public: 10705031056145
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/12/2022

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 Model Number: VCP945H
• Device Catalogue Number: VCP946H
• Device Lot Number: SA2ACQ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2022
• Supplement Date Received by Manufacturer: 08/03/2022; 08/10/2022; 09/09/2022
• Initial Report FDA Received Date: 06/10/2022
• Supplement Report FDA Received Date: 08/08/2022; 08/25/2022; 09/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown