MAUDE Adverse Event Report: CARDINAL HEALTH, INC. ARGYLE; CATHETER, UMBILICAL ARTERY

Model Number	8888160333
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2024
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 that he was assisting a dad in repositioning/transferring his baby.As the customer was doing so, the extended dwell peripheral intravenous catheter (edpiv) snapped at a connection site.The catheter remained in the baby and the exterior portion of the catheter remained secure under the dressing.The customer was able to remove the catheter completely without incidence.Additional information was received from the customer and stated that the part of the catheter that snapped (broke) was at 8 cm.Per customer, the catheter was retrieved right after it broke with tweezers.No surgery was necessary, and nothing was left in the baby.The providers opted to increase feeding volume to avoid putting in another extended dwell.
Event or Problem Description
The customer reported that when the umbilical catheter was flushed, a hole at the 20cm mark was observed, so it was removed.There was no patient harm reported.
Additional Manufacturer Narrative
Section b5 (describe event or problem): the customer has originally reported that ¿he was assisting a dad in repositioning/transferring his baby.As the customer was doing so, the extended dwell peripheral intravenous catheter (edpiv) snapped at a connection site.The catheter remained in the baby and the exterior portion of the catheter remained secure under the dressing.The customer was able to remove the catheter completely without incidence.Additional information was received from the customer and stated that the part of the catheter that snapped (broke) was at 8 cm.Per customer, the catheter was retrieved right after it broke with tweezers.No surgery was necessary, and nothing was left in the baby.The providers opted to increase feeding volume to avoid putting in another extended dwell¿ and the correct event description should be ¿the customer reported that when the umbilical catheter was flushed, a hole at the 20cm mark was observed, so it was removed.There was no patient harm reported" section d8 / d9 (device available for evaluation): originally reported by the customer as "yes" and should be "no" section h6 evaluation codes (health effect - clinical code): originally reported as 2687 foreign body in patient and should be 4582 no clinical signs, symptoms or conditions.Section h6 evaluation codes (medical device problem code): originally reported as 1069 break and should be 1250 fluid leak.
Additional Manufacturer Narrative
The device history record (dhr) for lot 2409600118 was reviewed and no anomalies related to the reported issue were observed.A sample was not received for the investigation.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.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: ARGYLE
• Common Device Name: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH, INC.; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20452518
• Report Number: 1423537-2024-00233
• Device Sequence Number: 9232184
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: (01)20884527005113(17)290307(10)2409600118
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K130725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/06/2024

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 Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 2409600118
• 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: 09/28/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 10/21/2024; 11/06/2024
• 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