MAUDE Adverse Event Report: ETHICON INC. PRONOVA BLU 36IN 5-0 D/A C-1; SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	PN3720H
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unknown cardiovascular surgery on an unknown date and suture was used.During the procedure, it was found that there was a foreign substance in the sterile package before opening the package.Thus, the product was not used.No adverse patient consequences were reported.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).Component code: g07002 - device not returned.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.If the device or further details are received at a later date a supplemental medwatch will be sent.The following information was requested, but unavailable: could you please clarify if the foreign substance could have been blood, insect, hair, or biological matter? please confirm no further information is available.Are there any photos available for visual analysis? no further information is available.What is the lot number? no further information is available.No further information will be provided".

• Brand Name: PRONOVA BLU 36IN 5-0 D/A C-1
• Common Device Name: SUTURE, NON-ABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15629676
• Report Number: 2210968-2022-08535
• Device Sequence Number: 18135323
• Product Code: GAT
• UDI-Device Identifier: 10705031246263
• UDI-Public: 10705031246263
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/18/2022

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: PN3720H
• Device Catalogue Number: PN3720H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 10/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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