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

Model Number	888570549K
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that during right minimally invasive thoracoscopic operation for a pneumothorax, a 28fr straight chest tube was placed through one of the incisions at the conclusion of the operation.On a postoperative film, the customer observed a radio-opaque structure along the chest tube in the soft tissue near the incision.This corresponds to the radio-opaque side hole of the tube that is cut by the manufacturer of the tube prior to packaging.Additional information was received from the customer and stated that there was no additional breakage to catheter, it was the cut out side hole piece.According to the customer, the piece was eventually removed from the patient.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) for lot: 2514911064 was reviewed and no anomalies related to the reported issue were observed.A photo was received for evaluation, and the reported condition was observed.The root cause appears to be an insufficient visual inspection during the assembly process, which allowed a residual fragment of the pierced eye to go undetected.As an action plan, a quality alert has been issued, and manufacturing personnel have been informed for awareness.Furthermore, the reported issue has been communicated to relevant staff for their information and comprehension.No corrective actions are warranted at this time.We will continue to track and trend through our monitoring programs and take actions as applicable.

• 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: 24274853
• Report Number: 1423537-2026-00026
• Device Sequence Number: 13267169
• Product Code: JOL
• UDI-Device Identifier: 10192253057348
• UDI-Public: (01)10192253057348(17)300430(10)2514911064
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 888570549K
• Device Catalogue Number: 888570549K
• Device Lot Number: 2514911064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2026
• Supplement Report FDA Received Date: 03/13/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White