MAUDE Adverse Event Report: CONMED CORPORATION VCARE MEDIUM (34MM) CUP

Catalog Number 60-6085-201

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The complaint device was received with the original unopened packaging.The lot number was verified from the packaging label.The product was observed to have a tear in the packaging's poly material adjacent to the product device's injection port cap.This resulted in an opening in the packaging material and therefore the product's sterility was breached.Due to the location and appearance of the defect area it is likely that the device caused the damaged to the packaging.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The products released for distribution were found to have met all specifications prior to shipment.Of the lot containing (b)(4) units, no prior complaints have been received for this failure mode.A two-year history complaint review revealed one similar complaint involving sixteen devices for this device family and failure mode.In this same timeframe, (b)(4) units have been manufactured and sold worldwide.The failure rate for this device family and failure mode, should all complaints have been confirmed, would be (b)(4).A risk analysis was performed and this failure was found to be acceptable.This reported packaging issue was obvious to the distributor, prompting the return of the device for evaluation.There was no patient involvement.As with all medical devices, examination of the product occurs multiple times prior to use.Good clinical practice would include examination and verification of the original packaging and its labeling to ensure both are intact.Per the ifu for this device, the user is advised: - inspect the device for damage and if damage is found to discard the device.This incident type will continue to be monitored through the complaint system to assure patient safety.

Event Description

The distributor in (b)(4) reported a "damage" on the sterile pouch of this 60-6085-201 device.There was no patient involvement as this defect was discovered during incoming inspection.This report is raised on the basis of a sterility breach found during the device evaluation.

• Brand Name: VCARE MEDIUM (34MM) CUP
• Type of Device: VCARE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 7331432
• MDR Text Key: 102339674
• Report Number: 1320894-2018-00059
• Device Sequence Number: 1
• Product Code: LKF
• UDI-Device Identifier: 20653405061806
• UDI-Public: (01)20653405061806(17)180725(30)8(10)201607251
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/25/2018
• Device Catalogue Number: 60-6085-201
• Device Lot Number: 201607251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1