MAUDE Adverse Event Report: ETHICON INC. PRNVA BLU 30IN 6-0 D/A C-1; SUTURE, NON ABSORBABLE, SYNTHETIC

Catalog Number	3706H
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	04/18/2019
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.
Event or Problem Description
It was reported that patient had unknown procedure on (b)(6) 2019.It was found that the needle had been came off from the tray when taking out the package from the box.The device was not used on the patient.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device batch mhr605-3706h and no non-conformances were identified.Additional h3 investigation summary: it was received for analysis an unopened sample of product code 3706, lot mhr605.During the visual inspection of the sealed sample, it was observed that a needle was not parked correctly in the slot of the winding former.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition the assignable cause of is incorrect needle park.

• Brand Name: PRNVA BLU 30IN 6-0 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: 8704362
• Report Number: 2210968-2019-82814
• Device Sequence Number: 1875766
• Product Code: GAW
• UDI-Device Identifier: 10705031004627
• UDI-Public: 10705031004627
• 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): 05/21/2019

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: 06/30/2023
• Device Catalogue Number: 3706H
• Device Lot Number: MHR605
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2019
• Initial Date Received by Manufacturer: 05/21/2019
• Supplement Date Received by Manufacturer: 06/25/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 07/20/2019
• Patient Sequence Number: 1