MAUDE Adverse Event Report: ETHICON INC. PRLNE BLU 18IN 6-0 S/A P-1 PRM; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8697G
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	05/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts are being 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 the patient underwent an unknown surgery on (b)(6) 2019 and suture was used.It was found that the suture had been protruded from the package before opening the package.There were no adverse consequences to the patient.
Additional Manufacturer Narrative
(b)(4).H3 device evaluation investigation summary = > it was reported packaging integrity.A sealed sample of product code 8697, lot # lph214 was returned for analysis.During the visual inspection of the sample, the suture was noted winding out of the plastic tray but, is not in an area that could be sealed in the packet.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the sample received the assignable cause of the packaging integrity is a suture(s) out of folder/tray.A manufacturing record evaluation was performed for the finished device lot number lph214, and no non-conformances related to the reported complaint condition were identified.

• Brand Name: PRLNE BLU 18IN 6-0 S/A P-1 PRM
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8737059
• Report Number: 2210968-2019-83324
• Device Sequence Number: 1832634
• Product Code: GAW
• UDI-Device Identifier: 10705031019218
• UDI-Public: 10705031019218
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133356
• 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): 06/04/2019

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: 11/30/2022
• Device Catalogue Number: 8697G
• Device Lot Number: LPH214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 06/04/2019
• Supplement Date Received by Manufacturer: 07/01/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/29/2019
• Patient Sequence Number: 1