MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC ARGYLE; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number	8888256545
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported the patient had critical replogle on suction for esophageal atresia.A kink and crack were noted to the replogle.They are unsure if it was a product quality issue.The tube may have had a weak spot that would kink if not held straight.
Additional Manufacturer Narrative
A device history record review could not be performed because a lot number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.There were no photos or physical samples received for investigation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations.Based on all available information we were unable to confirm the reported condition or determine the root cause.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If a sample is received at a later date the investigation will be updated accordingly.This complaint will be used for tracking and trending purposes.

• Brand Name: ARGYLE
• Common Device Name: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20395929
• Report Number: 1423537-2024-00197
• Device Sequence Number: 7842585
• Product Code: BSY
• UDI-Device Identifier: 10192253040173
• UDI-Public: (01)10192253040173
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2024

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
• Device Model Number: 8888256545
• Device Catalogue Number: 8888256545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/08/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown