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

Device Problem Difficult to Flush (1251)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Customer reports: the catheter obstructs very easily within a short time of use, even with suitable care.

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.

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
• Type of Device: 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
• MDR Text Key: 306340576
• Report Number: 3009211636-2022-00794
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 10884527004652
• UDI-Public: 10884527004652
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2022
• 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
• Date Manufacturer Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1