MAUDE Adverse Event Report: AV-TEMECULA-CT COPILOT BLEEDBACK CONTROL VALVE; HEMOSTATIC VALVE

Catalog Number 1003331

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 02/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for analysis.A conclusive cause for the reported unsealed packaging could not be determined.A review of the lot history record and complaint history of the reported device could not be conducted because the lot number was not provided.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that when the copilot was removed from the box, the package was already open 1 to 2 inches on the top where it was supposed to be completely sealed.This device was not used in the patient.Another copilot was used to complete the procedure.No additional information was provided.

• Brand Name: COPILOT BLEEDBACK CONTROL VALVE
• Type of Device: HEMOSTATIC VALVE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 6376826
• MDR Text Key: 69282841
• Report Number: 2024168-2017-01768
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013997
• UDI-Public: (01)08717648013997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991102
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1003331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1