MAUDE Adverse Event Report: ETHICON INC. PDS PLUS CLR 18IN 4-0 S/A P-3 PRM MP; SUTURE, SURGICAL, ABSORBABLE

Model Number	PDP494G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
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.(b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: did the needle break off? the needle was bent.Please provide the lot number for the involved device.No further information is available.No further information will be provided.Additional information received at a later date: during use on the dermis, the tip of the needle broke and was found in the fat.During suturing, the needle tip suddenly became dull, and when the needle tip was checked, the needle tip was missing.Subsequently, the area around the fat was palpated and the needle tip was found.Thereafter, there was no problem with the patient's condition.Trade name - irgacare¿.Active ingredient(s)  triclosan.Dosage form  suture/solid/parenteral.Strength  2360 g/m.
Event or Problem Description
It was reported that a patient underwent an unknown urological surgery on (b)(6) 2021 and suture was used.During use on the dermis, the needle tip suddenly became dull, and when the needle tip was checked, the needle tip was missing.Subsequently, the area around the fat was palpated and the needle tip was found.There were no adverse patient consequences.No additional information was provided.

• Brand Name: PDS PLUS CLR 18IN 4-0 S/A P-3 PRM MP
• Common Device Name: SUTURE, SURGICAL, ABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 11452516
• Report Number: 2210968-2021-02190
• Device Sequence Number: 14292794
• Product Code: NEW
• UDI-Device Identifier: 10705031048416
• UDI-Public: 10705031048416
• 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
• Report Date (Section B): 02/12/2021

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: PDP494G
• Device Catalogue Number: PDP494G
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 03/10/2021
• Patient Sequence Number: 1