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

Catalog Number 1003331

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Patient Involvement (2645)

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported packaging damage was able to be confirmed.The pouch seals were intact.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents from this lot.It is possible that the pouch was inadvertently mishandled during shipment or receiving/storage at the account resulting in the reported packaging damage/noted pouch tear; however, this could not be confirmed.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that while unpacking the device, the paper portion was found torn and there was a breach in sterility.The device was set aside for return and not used in any procedure.There was no patient involvement.There was no additional information provided regarding this device issue.

• 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: 7370711
• MDR Text Key: 103827423
• Report Number: 2024168-2018-02175
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 08717648013997
• UDI-Public: 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: health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 1003331
• Device Lot Number: 60101090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2017
• 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