MAUDE Adverse Event Report: ETHICON INC. PRONOVA SUTURE 30"(75CM) 6-0 BLU; SUTURE, NON ABSORBABLE, SYNTHETIC

Model Number	M3709
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	07/05/2021
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.The following information was requested, but unavailable: what was the name of the procedure? what is the lot number of the involved product? was the suture seals on the foil still intact when the package was opened? no further information will be provided.Additional information was requested and the following was obtained: are there any photos of the foreign matter available found in the package? no photos are available.
Event or Problem Description
It was reported that a patient underwent an unknown surgery on (b)(6) 2021 and suture was used.During the procedure, it was found that there had been a foreign substance inside the film of the package like a human hair.There were no adverse consequences to the patient.No additional information was provided.

• Brand Name: PRONOVA SUTURE 30"(75CM) 6-0 BLU
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12260110
• Report Number: 2210968-2021-06892
• Device Sequence Number: 11682869
• Product Code: GAW
• UDI-Device Identifier: 10705031045149
• UDI-Public: 10705031045149
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/07/2021

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: M3709
• Device Catalogue Number: M3709
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 08/02/2021
• Patient Sequence Number: 1