MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. CNRV CARDIAC CATH SET-UP PACK; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	89-10519
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received on 03/04/2024 reporting manifold piece cracked and allowing air to closed system for 89-10149 lot # 59673980.However, the lot number was determined to be for 89-10519.The sample has not been returned to deroyal for evaluation at this time.A supplier corrective action request (scar) was issued to the manifold supplier merit medical systems, inc.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Event or Problem Description
Manifold piece cracked and allowing air to closed system.
Additional Manufacturer Narrative
A user facility medwatch report (#(b)(4)) was received on 03/04/2024 reporting manifold piece cracked and allowing air to closed system for 89-10149 lot # 59673980.However, the lot number was determined to be for 89-10519.A picture of the sample was provided.A supplier corrective action request (scar) was issued to the manifold supplier merit medical systems, inc.The true root cause was unable to be determined by the supplier merit medical system, inc.However, potential causes for leaking have been determined to be caused by crazing/cracking.Potential causes that can lead to cracks have been determined to be from bending/hitting/mishandling the components, bonding issues, overtightening, chemical interaction between hard-to-hard components and extreme temperatures.This defect could have occurred at any time from the point of manufacture to the point of end user.We could not determine when, where, or how the damage occurred in this case.Due to the root cause finding, there were no corrective and preventive actions taken by merit medical system, inc.Production records were reviewed by deroyal, and no issues were found.An inventory check of the manifold was made by deroyal, a total of (b)(4) were visually inspected, and no discrepancies were identified during the inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.
Additional Manufacturer Narrative
A user facility medwatch report (b)(4) was received on 03/04/2024 reporting manifold piece cracked and allowing air to closed system for 89-10149 lot # 59673980.However, the lot number was determined to be for 89-10519.A picture of the sample was provided.A supplier corrective action request (scar) was issued to the manifold supplier merit medical systems, inc.The true root cause was unable to be determined by the supplier merit medical system, inc.However, potential causes for leaking have been determined to be caused by crazing/cracking.Potential causes that can lead to cracks have been determined to be from bending/hitting/mishandling the components, bonding issues, overtightening, chemical interaction between hard-to-hard components and extreme temperatures.This defect could have occurred at any time from the point of manufacture to the point of end user.We could not determine when, where, or how the damage occurred in this case.Due to the root cause finding there were no corrective and preventive actions taken by merit medical system, inc.Production records were reviewed by deroyal, and no issues were found.An inventory check of the manifold was made by deroyal, a total of (b)(4) of the (b)(4) were visually inspected, and no discrepancies were identified during the inspection.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if additional information becomes available.

• Brand Name: CNRV CARDIAC CATH SET-UP PACK
• Common Device Name: ANGIOGRAPHY/ANGIOPLASTY KIT
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: melissa logsdon ; 200 debusk lane; powell, TN 37849 ; 8653626157
• MDR Report Key: 18886417
• Report Number: 3005011024-2024-00009
• Device Sequence Number: 7774070
• Product Code: OEQ
• UDI-Device Identifier: 00749756364348
• UDI-Public: 00749756364348
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: ENFDISC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/22/2024

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
• Device Model Number: 89-10519
• Device Lot Number: 59673980
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/04/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/12/2024
• Supplement Report FDA Received Date: 07/02/2024; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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