MAUDE Adverse Event Report: CORDIS US. CORP INFINITI; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	534619T
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 6f 100cm judkins right (jr) 3.5 infinity diagnostic catheter was contaminated due to the observation of a hair inside of the ¿bag¿.There was no reported injury to the patient and the device will be returned for evaluation.
Additional Manufacturer Narrative
This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a 6f 100cm judkins right (jr) 3.5 infinity diagnostic catheter was contaminated due to the observation of a hair inside of the ¿bag¿.There was no reported injury to the patient.Additional information was requested but was not provided.The device has now been returned.
Event or Problem Description
As reported, a 6f 100cm judkins right (jr) 3.5 infinity diagnostic catheter was contaminated due to the observation of a hair inside of the ¿bag¿.There was no reported injury to the patient.Additional information was requested but was not provided.The device was not returned as expected.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, b5, d4, d9, g3, g6, h1, h2, h3, h6, and h10 a review of the manufacturing documentation associated with lot 18160752 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Compliant conclusion: as reported, a 6f 100cm judkins right (jr) 3.5 infinity diagnostic catheter was contaminated due to the observation of a hair inside of the ¿bag¿.There was no reported injury to the patient.Two pictures were received for analysis and show a section of the pouch with foreign material near the sealed section of the pouch.It appears to be a hair or long fiber.A sterile unit of ¿cath f6inf tl jr 3.5 100cm¿ was subsequently received for analysis.The pouch seals were received intact, and the sterility was not compromised.During visual inspection, a hair with a length of approximately 3 cm was noted inside the sterile packaging.The unit was inspected with a vision system to obtain a magnified image confirming the presence of a hair inside the pouch.Ftir results confirmed the fiber inside the pouch is hair.A product history record (phr) review of lot 18160752 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The complaint reported by the customer as ¿packaging/pouch/box ~ foreign material in sterile package-moveable particle¿ was confirmed.According to the visual inspection through the vision system and the infrared spectrum, the foreign material found inside the sealed sterile package is hair.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿do not use if package is open or damaged.¿ per analysis of the returned device, foreign material inside the sterile pouch was found to be manufacturing related and a risk assessment was initiated to address this issue no further actions will be taken.

• Brand Name: INFINITI
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS US. CORP; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, florida 33014 ; 7863138372
• MDR Report Key: 17013166
• Report Number: 9616099-2023-06503
• Device Sequence Number: 12520546
• Product Code: DQO
• UDI-Device Identifier: 10705032014175
• UDI-Public: (01)10705032014175(17)251031(10)18160752
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/15/2023

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 Expiration Date: 10/31/2025
• Device Catalogue Number: 534619T
• Device Lot Number: 18160752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 07/04/2023; 08/29/2023; 11/08/2023
• Initial Report FDA Received Date: 05/26/2023
• Supplement Report FDA Received Date: 07/28/2023; 09/22/2023; 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.
• Patient Sex: Unknown