MAUDE Adverse Event Report: ETHICON INC. VICRYL SUTURE 18"(45CM) 1 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	JB725
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.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 a patient underwent an unknown procedure on (b)(6) 2019 and suture was used.During the procedure, before opening the package, it was found that there had been a foreign substance like 2 ¿ 3 cm hair in the package.There were no adverse consequences to the patient.No additional information was provided.
Additional Manufacturer Narrative
Product complaint #: (b)(4).A sealed box of product code jb725, lot # pbk081 was returned for evaluation.During the visual inspection of sealed box, a foreign matter (hair) was observed under film of the box.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to sample condition the assignable cause of the foreign matter is a hair.

• Brand Name: VICRYL SUTURE 18"(45CM) 1 UND
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8726807
• Report Number: 2210968-2019-83176
• Device Sequence Number: 19333811
• Product Code: GAM
• UDI-Device Identifier: 10705031043961
• UDI-Public: 10705031043961
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K022269
• 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): 05/29/2019

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: 01/31/2024
• Device Catalogue Number: JB725
• Device Lot Number: PBK081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 05/29/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 09/27/2019
• Patient Sequence Number: 1