MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. INFLATION DEVICE.BLUE DIAMOND TOUCH; GAS CONTROL INFLATION DEVICE,

Model Number	IN7152/C
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was returned for evaluation.The device was visually investigated.The complaint is confirmed.The root cause is attributed to the manufacturing process.The device history record was reviewed, and no exception documents were identified.A search of the complaint database was performed and 5 similar complaints for this lot number were identified.
Event or Problem Description
The account alleges that when prepping for an interventional procedure, there was a defect identified in the packaging resulting in incomplete sterilization of the contents.The packaging defect was not intuitively obvious.No patient contact or patient injury to report.A new device was used to complete the procedure.

• Brand Name: INFLATION DEVICE.BLUE DIAMOND TOUCH
• Common Device Name: GAS CONTROL INFLATION DEVICE,
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012088662
• MDR Report Key: 19657329
• Report Number: 1721504-2024-00033
• Device Sequence Number: 6848305
• Product Code: DTX
• UDI-Device Identifier: 00884450381168
• UDI-Public: 884450381168
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K160107
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/04/2024

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: IN7152/C
• Device Lot Number: H2918432
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Initial Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown