MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS MERIT CUSTOM KIT; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number 00884450476673

Device Problems Unsealed Device Packaging (1444); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.A review of the device history and complaint database could not be performed since the lot number was not provided.

Event Description

The account alleges that the inner blue table cover wrap has fallen out of the outer clear packaging because the pack was not sealed correctly at one end.Some packs also have a weak seal.The blue table cover will fall out onto the floor if the pack is held at the wrong end when removing the pack from the shipping box or the storage shelf.No patient injury to report.

• Brand Name: MERIT CUSTOM KIT
• Type of Device: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 12701 kingston ave; richmond VA 23836
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS; 12701 kingston ave; richmond VA 23836
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 10823428
• MDR Text Key: 217366047
• Report Number: 1125782-2020-00013
• Device Sequence Number: 1
• Product Code: OEQ
• UDI-Device Identifier: 00884450476673
• UDI-Public: 00884450476673
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450476673
• Device Catalogue Number: K12T-10996B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2020
• 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