MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC ARGYLE; CATHETER AND TIP, SUCTION

Model Number	5558505136
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 that it was found that there was a crack in the item.
Additional Manufacturer Narrative
The device history record (dhr) for lot number 2506207764 was reviewed and no anomalies related to the reported issue were observed.The physical device was received for evaluation and the reported condition was observed; however, a definitive root cause could not be determined.Based on this information, no corrective actions are warranted at this time.We will continue to track and trend through our monitoring programs and take actions as applicable.
Additional Manufacturer Narrative
The device history record (dhr) for lot number 2506207764 was reviewed and no anomalies related to the reported issue were observed.The physical device was received for evaluation.Upon technical evaluation, it was decided to dissect the returned device to corroborate the reported condition.Only minor marks were observed; no cracks were identified on the returned sample.Functional tests, including a leak test, were performed, and no leaks were detected.Based on these findings, the reported issue has been classified as cosmetic, as it does not impact on the product¿s form or function.Based on this information, no corrective actions are warranted at this time.We will continue to track and trend through our monitoring programs and take actions as applicable.Section h6 evaluation codes: investigation findings and investigation conclusions have been corrected.Section h10 additional manufacturer narrative has been corrected.

• Brand Name: ARGYLE
• Common Device Name: CATHETER AND TIP, SUCTION
• 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: 22081479
• Report Number: 1423537-2025-00210
• Device Sequence Number: 8703430
• Product Code: JOL
• UDI-Device Identifier: 50192253042779
• UDI-Public: (01)50192253042779(10)2506207764
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2025

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: 5558505136
• Device Catalogue Number: 5558505136
• Device Lot Number: 2506207764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/25/2025; 07/11/2025
• 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