MAUDE Adverse Event Report: ETHICON INC. VCL CT BRD VIO 8X18IN 0 S/A CT-2 CR; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	J727D
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device pem446 batch number, 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 the patient underwent an unknown procedure on (b)(6) 2019 and suture was used.When opening the package, it was found that a foreign substance like a hair was in the package.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
(b)(4).It was reported foreign matter biological.One empty opened foil and a winding former with eight needle-suture combinations of product code j727, lot pem446 were received for analysis.During visual inspection of the sample, a yellow substance was observed on the tray.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.

• Brand Name: VCL CT BRD VIO 8X18IN 0 S/A CT-2 CR
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9267842
• Report Number: 2210968-2019-89397
• Device Sequence Number: 1850379
• Product Code: GAM
• UDI-Device Identifier: 10705031042582
• UDI-Public: 10705031042582
• 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): 10/07/2019

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: 04/30/2024
• Device Catalogue Number: J727D
• Device Lot Number: PEM446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Initial Date Received by Manufacturer: 10/07/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 11/25/2019
• Patient Sequence Number: 1