MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. 3 PORT MANIFOLD KIT; ANGIOGRAPHY/ANGIOPLASTY KIT

Model Number	35-401106
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medical professional was unable to balance transducer during procedure.Customer did trouble shooting different cables but determined issue was with transducer.Length of delay was not reported.
Additional Manufacturer Narrative
A complaint was received on( b)(6) 2023 reporting medical professional was unable to balance transducer during procedure.Customer did trouble shooting different cables but determined issue was with transducer.Length of delay was not reported.A supplier corrective action request (scar) was issued to the transducer supplier ca-icu medical, inc.The sample has not been returned to deroyal for evaluation at this time.This investigation is ongoing 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 complaint was received on 3/27/2023 reporting medical professional was unable to balance transducer during procedure.Customer did trouble shooting different cables but determined issue was with transducer.Length of delay was not reported.A supplier corrective action request (scar) was issued to the transducer supplier ca-icu medical, inc.Samples were returned and investigated.A visual evaluation of sample one showed corrosion on the transpac connector.The transducer was electrically tested and could not be zeroed.The corrosion on the transducer was cleaned and retested.The transducer was still not able to be zeroed.The sample was primed, pressure leak tested, and no leakage was observed.The blue housing was disassembled, and the internal componentry was examined.No anomalies were observed, which could lead to no reading.The reported issue was confirmed.However, at this time, the exact root cause(s) of no reading could not be determined.A visual evaluation of sample two showed no visible defects or anomalies.The transducer was electrically tested and could not be zeroed.The sample was primed, and pressure leak tested, and no leakage was observed.The blue housing was disassembled, and the internal componentry was examined.No anomalies were observed, which could lead to no reading.The reported issue was confirmed.However, at this time, the exact root cause(s) of no reading could not be determined.A visual evaluation of sample three showed no visible defects or anomalies.The transducer was electrically tested and was able to be zeroed, with waveforms present in the monitor.A bend and twist test were conducted on the cable, and no interruptions were observed on the monitor.The sample met product performance specifications.The reported issue was not confirmed.Due to no root cause being determined there were no corrective and preventive actions taken by ca-icu medical, inc.This report and the associated information have been entered into ca-icu medicals database for close monitoring and trending.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: 3 PORT MANIFOLD KIT
• 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
• MDR Report Key: 16682692
• Report Number: 3005011024-2023-00018
• Device Sequence Number: 12565208
• Product Code: OEQ
• UDI-Device Identifier: 00749756371803
• UDI-Public: 00749756371803
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2023

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: 35-401106
• Device Catalogue Number: 35-401106
• Device Lot Number: 57587121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 03/27/2023
• Initial Report FDA Received Date: 04/05/2023
• Supplement Report FDA Received Date: 06/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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