MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC - SJ MANIFOLD.3 PORT.HALF BODY; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Catalog Number	503HN-R/CNA
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	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device was not returned for evaluation.A photograph was provided by the account.The complaint is confirmed but the root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be reopened.
Event or Problem Description
The account alleges that there was a defect in the packaging processes resulting in incomplete sterilization of the contents.The defect was identified during preparations for a medical procedure.No patient interaction or injury to report.

• Brand Name: MANIFOLD.3 PORT.HALF BODY
• Common Device Name: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC - SJ; 1600 merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC - SJ; 1600 merit parkway; south jordan UT 84095
• Manufacturer Contact: bryson heaton r.n. ; 1600 merit pky; south jordan, UT 84095 ; 8012665654
• MDR Report Key: 20857047
• Report Number: 1721504-2024-00082
• Device Sequence Number: 11728116
• Product Code: DTL
• UDI-Device Identifier: 00884450018965
• UDI-Public: 884450018965
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/18/2024

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 Catalogue Number: 503HN-R/CNA
• Device Lot Number: H2977538
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 12/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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