MAUDE Adverse Event Report: ETHICON INC. PRONOVA SUTURE 24"(60CM) 7-0 BLU; SUTURE, NON ABSORBABLE, SYNTHETIC

Model Number	M3702
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown cardiovascular procedure on 12/27/2021 and suture was used.After the package was opened, there was a foreign matter stuck in the needle park foam.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Investigation summary: one opened straight-pack folder with four undispensed needle-sutures product code m3702 was returned for analysis.The product code should be multistrand and each straight-pack folder must contain four strands single-armed.As per visual analysis of the sample received a foreign matter (hair) caught in a section of the foam park was observed.Based on the information currently available, the foreign matter was identified during the investigation of the sample received.A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

• Brand Name: PRONOVA SUTURE 24"(60CM) 7-0 BLU
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-SAN LORENZO PR; road 183, km. 8.3; san lorenzo 00754 ; * 00754
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 14021971
• Report Number: 2210968-2022-02401
• Device Sequence Number: 6172002
• Product Code: GAW
• UDI-Device Identifier: 10705031045118
• UDI-Public: 10705031045118
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/06/2022

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 Expiration Date: 09/30/2025
• Device Model Number: M3702
• Device Catalogue Number: M3702
• Device Lot Number: QLBDMP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2022
• Initial Report FDA Received Date: 04/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown