MAUDE Adverse Event Report: MERIT MEDICAL RICHMOND MERIT CUSTOM KIT

Catalog Number K09T-10728D

Device Problems Tear, Rip or Hole in Device Packaging (2385); Device Packaging Compromised (2916); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2017

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that they received an angio tray that had a hole in the header bag.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint is confirmed.The root cause could not be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints were found for this lot number.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: MERIT CUSTOM KIT
• Manufacturer (Section D): MERIT MEDICAL RICHMOND; 12701 n kingston ave; chester VA 23836
• Manufacturer (Section G): MERIT MEDICAL RICHMOND; 12701 n kingston ave; chester VA 23836
• Manufacturer Contact: casey hughes ms, cqe, csqp ; 1600 merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6511053
• MDR Text Key: 73379885
• Report Number: 1125782-2017-00006
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K913682
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/31/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: K09T-10728D
• Device Lot Number: T1077686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2017
• Initial Date FDA Received: 04/21/2017
• Supplement Dates Manufacturer Received: 07/06/2017
• Supplement Dates FDA Received: 07/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2017
• 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