MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.R.L 48'' HPL CPC R/A -F; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	301220A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported, "defective tubing - hub snapped off during the case and the contrast was spraying everywhere".
Additional Manufacturer Narrative
A distributing facility reported on 6/23/2023 that "defective tubing - hub snapped off during the case and the contrast was spraying everywhere." the sample was requested and received on 7/13/2023.Deroyal industries requested that the initial reporter and distributor, medline, reach out to the user facility to gain further information on the incident.This investigation is not complete at this time.No further information is available at this time.We will provide follow-up report once more information becomes available.
Additional Manufacturer Narrative
Deroyal industries requested that the initial reporter and distributor, medline, reach out to the user facility to gain further information on the incident.However, medline was not able to gain any further information from the customer who had the issue.Deroyal checked work orders, current inventory, failure modes and effect analysis (fmea's), and corrective actions and preventive actions (capa's) and all were found to have no issues and no open actions.The sample returned was decontaminated and inspected.It was noted that the rotator of the tubing had fallen out.Production records were reviewed and both in-line and final inspections were noted to have passed.Hydrostatic tests were also noted to have been within range.(b)(4).Root cause: because no abnormality could be found based on the investigation of the sample returned and inspection of production records, the root cause was unable to be established.Corrective and preventive actions: because no root cause could be established, no corrective or preventive actions were taken.This investigation is complete at this time.No further information is available at this time.We will provide follow-up report if more information becomes available.

• Brand Name: 48'' HPL CPC R/A -F
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago ; DR
• Manufacturer (Section G): DEROYAL INTERCONTINENTAL, S.R.L; km 7 autopista joaquin balague; pisano free zone bldg 49; santiago, ; DR
• Manufacturer Contact: reagan newman ; 200 debusk lane; powell, TN 37849 ; 8653622106
• MDR Report Key: 19950051
• Report Number: 3004605321-2023-00001
• Device Sequence Number: 15684298
• Product Code: DQO
• UDI-Device Identifier: 00749756719407
• UDI-Public: 00749756719407
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K023591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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: 301220A
• Device Lot Number: 52516359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 08/09/2024
• 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