MAUDE Adverse Event Report: CARDINAL HEALTH 1.9 FR ARGYLE DUAL LUMEN PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	43304
Medical Device Problem Code	Difficult to Flush (1251)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the catheter obstructs very easily within a short time of use, even with suitable care.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.Device evaluation comment - the customer stated that the device will not be returned for evaluation because it was used.
Additional Manufacturer Narrative
A device history record confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site did not receive a sample with this customer report.No additional information, pictures or videos were received.Consequently, it was not possible to evaluate it as part of a comprehensive investigation.A corrective/preventative action had been opened to address the reported issue.Based on the capa investigation the probable cause was interaction between the extruded tube inner diameter (id) and the molding pin outer diameter (od) that can affect the tube variability and the pin id interaction on the manufacturing line, could potentially cause partially detached residual material that partially occludes the tube.

• Brand Name: 1.9 FR ARGYLE DUAL LUMEN PICC
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 15469736
• Report Number: 3009211636-2022-00794
• Device Sequence Number: 11832611
• Product Code: LJS
• UDI-Device Identifier: 10884527004652
• UDI-Public: 10884527004652
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 10/05/2022

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: 43304
• Device Catalogue Number: 43304
• Device Lot Number: 1914100109
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 09/20/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/05/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown