MAUDE Adverse Event Report: ETHICON INC. PDS+ VIO 36IN 1 S/A CTX; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP371T
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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.A manufacturing record evaluation was performed for the finished device batch number qjmssl, and no non-conformances were identified.Additional information was requested and the following information was obtained: please provide procedure name and date: no further information is available.Did the needle break at the tip or at the body? no further information is available.Is the broken needle available for analysis? no sample will be returned.Any photos available for visual analysis? no photos are available.How was procedure successfully completed? no further information is available.No further information will be provided.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and suture was used.During the procedure, the needle broke.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 10/14/2021.H6 component code: g07002 - device not returned.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.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.The following information was requested, but unavailable: please provide procedure name and date: no further information is available.Did the needle break at the tip or at the body? no further information is available.Is the broken needle available for analysis? no sample will be returned.Any photos available for visual analysis? no photos are available.How was procedure successfully completed? no further information is available.No further information will be provided.Trade name - irgacare® active.Ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ 275 g/m.

• Brand Name: PDS+ VIO 36IN 1 S/A CTX
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12583144
• Report Number: 2210968-2021-09245
• Device Sequence Number: 3787665
• Product Code: NEW
• UDI-Device Identifier: 10705031048201
• UDI-Public: 10705031048201
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K061037
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2021

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: 07/31/2022
• Device Model Number: PDP371T
• Device Catalogue Number: PDP371T
• Device Lot Number: QJMSSL
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/08/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 10/14/2021
• Patient Sequence Number: 1