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

Catalog Number	3720H
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts have been 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.Additional information was requested and the following was obtained: what do you mean by ""needle had penetrated the package""? did the needle stick out of the package causing a puncture / hole / tear in package and compromising integrity and sterility of the product in any way? yes.Was the package opened to check the product? unknown.Was the needle incorrectly assembled in package causing needle park issues? unknown.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on (b)(6) 2018 and suture was used.It was found that the needle had penetrated the package before opening the package.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
Product complaint # pc-(b)(4).Date sent to the fda: (b)(4) 2018.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

• Brand Name: PRONOVA BLU 36IN 5-0 D/A C-1
• Common Device Name: SUTURE, NON ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7699724
• Report Number: 2210968-2018-74493
• Device Sequence Number: 1329405
• Product Code: GAW
• UDI-Device Identifier: 10705031004689
• UDI-Public: 10705031004689
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K001625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2018

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: 02/28/2023
• Device Catalogue Number: 3720H
• Device Lot Number: MCH771
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 07/18/2018
• Initial Report FDA Received Date: 07/18/2018
• Supplement Report FDA Received Date: 08/07/2018
• Patient Sequence Number: 1