MAUDE Adverse Event Report: ETHICON INC. SFX SPI PDO BI VIO 36CM2 1 D/A MO-4; SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25)

Model Number	SXPD2B400
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).This is a combination product, and the event has been reviewed for both the suture and the triclosan.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.Can you identify the lot number(s) of the products that were used? were the ¿missing barbs¿ noted during visual inspection or during use on patient? were there any patient consequences? 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.(b)(4).Trade name - irgacare®.Active ingredient(s) ¿ triclosan.Dosage form ¿ suture/solid/parenteral.Strength ¿ = 2360 ¿g/m.Related events reported via 2210968-2021-05358.
Event or Problem Description
It was reported that a patient underwent an unspecified plastic surgery procedure on (b)(6) 2021 and suture was used.The suture used had no barbs on it (smooth with no grab).A new like product was opened and the case was completed successfully.There were no adverse patient consequences.Additional information has been requested.

• Brand Name: SFX SPI PDO BI VIO 36CM2 1 D/A MO-4
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE, (POLIGLECAPRONE 25)
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11959894
• Report Number: 2210968-2021-05357
• Device Sequence Number: 4247083
• Product Code: NEW
• UDI-Device Identifier: 10705031207974
• UDI-Public: 10705031207974
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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 Model Number: SXPD2B400
• Device Catalogue Number: SXPD2B400
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 06/08/2021
• Patient Sequence Number: 1