MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; CATHETER AND TIP, SUCTION

Model Number	8888570549
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/25/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that there was a partial dislodge of chest tube with exposed eyelet and suture fell off.No unusual circumstances noted.The clinical staff noticed worsening air leak and informed the team.The nurse practitioner (np) and surgeon came to assess and discovered partial dislodge.The chest tube was removed.The patient deteriorated over the next few days, transferred to icu and intubated.This was most likely due to underlying clinical factors, but the chest tube dislodges likely contributed to deterioration as well (<50%).It is very unusual to have a partial dislodge with eyelet exposure, so they had to provide additional staff education and update their policy to include this situation.Per customer, the chest tube was in for 5 days.Additional information was received from the customer and stated that there was no detachment, splits or breaks.Due to the tube being very rigid and difficult to suture to the chest wall, an eyelet that should have been below the dermis in the chest wall to facilitate drainage was exposed.The patient had multiple comorbidities; deterioration not likely due to the partial dislodge.Patient deterioration was attributed to patient sedation and respiratory acidosis.The patient was intermittently confused and refusing high flow non-rebreather mask, bipap and optiflow with rt.The patient died in icu.
Additional Manufacturer Narrative
Section d4 (model number and catalog number): originally reported as 8888571042 and should be 8888570549.Section g3/g4 (pma/510(k)number): originally reported as e223935 and should be exempt.
Additional Manufacturer Narrative
The device history record for lot 2327900464 was reviewed and no anomalies related to the reported issue were observed.The device was manufactured on october 10, 2023.There were no photos or physical samples received for evaluation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.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.

• Brand Name: ARGYLE
• Common Device Name: CATHETER AND TIP, SUCTION
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH, INC.; 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: 21160650
• Report Number: 1423537-2025-00033
• Device Sequence Number: 8520431
• Product Code: JOL
• UDI-Device Identifier: 10884521050846
• UDI-Public: (01)10884521050846(17)280930(10)2327900464
• 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: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 8888570549
• Device Catalogue Number: 8888570549
• Device Lot Number: 2327900464
• 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: 12/31/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 01/17/2025; 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown