MAUDE Adverse Event Report: CORDIS CORPORATION CATH F6 INF TL JL 3.5 100 CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	534618T
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	09/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, a foreign material (hair) was found in the inner package of the product.There was no reported injury to the patient.The outer box was not damaged.The integrity of the sterile pouch was not compromised.The damage was noted to have happened during the time of over-labeling activity in custom bonded warehouse.The device was not stored in the lab, it was maintained in a warehouse.The device will be returned for evaluation.
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18129323 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
After further review of additional information received the following sections have been updated accordingly: b4, g3, h1, h2, h3 after further clarification and review of events, the code of packaging/pouch-foreign material - in sterile package will be changed to "no adverse event" as the device did not reach the customer.The file is now non-reportable.
Event or Problem Description
As reported, a foreign material (hair) was found in the inner package of the 6f infinity jl 3.5 device.There was no reported injury to the patient.The outer box was not damaged.The integrity of the sterile pouch was not compromised.The foreign material was found prior to reaching the customer.The damage was noted to have happened during the time of over-labeling activity in custom bonded warehouse.The device was not stored in the lab, it was maintained in a warehouse.The device will be returned for evaluation.
Event or Problem Description
As reported, a foreign material (hair) was found in the inner package of the 6f infinity jl 3.5 device.There was no reported injury to the patient.The outer box was not damaged.The integrity of the sterile pouch was not compromised.The damage was noted to have happened during the time of over-labeling activity in custom bonded warehouse.The device was not stored in the lab, it was maintained in a warehouse.The device will be returned for evaluation.
Additional Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b4, g3, h1, h2, h3 and h6.This device is available for analysis but has not yet been received.
Event or Problem Description
As reported, a foreign material (hair) was found in the inner package of the 6f infinity jl 3.5 device.There was no reported injury to the patient.The outer box was not damaged.The integrity of the sterile pouch was not compromised.The damage was noted to have happened during the time of over-labeling activity in custom bonded warehouse.The device was not stored in the lab, it was maintained in a warehouse.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.

• Brand Name: CATH F6 INF TL JL 3.5 100 CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 15553252
• Report Number: 9616099-2022-06044
• Device Sequence Number: 2984388
• Product Code: DQO
• UDI-Device Identifier: 10705032014168
• UDI-Public: (01)10705032014168(17)250630(10)18129323
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K970854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/10/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: 534618T
• Device Catalogue Number: 534618T
• Device Lot Number: 18129323
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2022
• Supplement Date Received by Manufacturer: 11/08/2022; 10/26/2022; 02/13/2023
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 11/01/2022; 11/20/2022; 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2022
• 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
• Patient Sex: Unknown