MAUDE Adverse Event Report: CORDIS US CORP. BRITE TIP; INTRODUCER, CATHETER

Catalog Number	401735M
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	12/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, it looks like there is some sort of ointment at the tip inside the sterile package of a 7f 35cm brite tip sheath introducer.The condition was noted after the product had been received, and stored in the lab, prior to using.There was no reported patient injury.There was no packaging damage noted, no damage to the shipping box, to the outer product box or the inner product pouch.The sterile pouch was not received open/compromised and it was not damaged.The product was not purposely opened in anticipation of use, and had not been reshelved.The device is expected to be retuned for evaluation.
Additional Manufacturer Narrative
The device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
As reported, it looks like there is some sort of ointment at the tip inside the sterile package of a 7f 35cm brite tip sheath introducer.The condition was noted after the product had been received, and stored in the lab, prior to using.There was no reported patient injury.There was no packaging damage noted, no damage to the shipping box, to the outer product box or the inner product pouch.The sterile pouch was not received open/compromised and it was not damaged.The product was not purposely opened in anticipation of use and had not been reshelved.The product was not returned for analysis.Without the return of the device or images for analysis, the reported customer event ¿catheter sheath introducer (csi)-foreign material¿ could not be confirmed.Procedural/handling factors may have contributed to the reported event.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, ¿store in a dry, dark, cool place.Do not use if package is open or damaged.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.
Additional Manufacturer Narrative
After further review, section d.4 primary unique device identification (udi) number has been corrected accordingly.

• Brand Name: BRITE TIP
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; santiago troncoso 808; juarez, chihuahua ; 7863138372
• MDR Report Key: 18363800
• Report Number: 9616099-2023-06666
• Device Sequence Number: 8014357
• Product Code: DYB
• UDI-Device Identifier: 10705032000321
• UDI-Public: (01)10705032000321(17)260131(10)18188241
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K984500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2026
• Device Catalogue Number: 401735M
• Device Lot Number: 18188241
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 01/16/2024; 08/15/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 01/17/2024; 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2023
• 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