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

Model Number	00884450476673
Medical Device Problem Codes	Unsealed Device Packaging (1444); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS; 12701 kingston ave; richmond VA 23836
• MDR Report Key: 10823398
• Report Number: 1125782-2020-00006
• Device Sequence Number: 19773193
• Product Code: OEQ
• UDI-Device Identifier: 00884450476673
• UDI-Public: 00884450476673
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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
• Operator of Device: Health Professional
• Device Model Number: 00884450476673
• Device Catalogue Number: K12T-10996B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2020
• Initial Report FDA Received Date: 11/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1