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

Model Number 43303

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 01/04/2023

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

The customer reported the nurse was assessing the patient and noticed a small drop of fluid leak on to patient's abdomen.Upon further assessment, it was noted the patient's peripherally inserted central catheter (picc) line in the right accessory cephalic vein had a small leak from the line as if there was a crack in the line.Charge nurse was notified to come assess and neonatal nurse practitioner (nnp) was called.Nnp ordered picc line to be removed.Charge nurse removed the line, started a peripheral intravenous line (piv), and restarted fluids, 1x dose of vancomycin given per nnp order.Per additional information provided on january 18, 2023, the vancomycin was given prophylactically because the central line was compromised.

Manufacturer Narrative

Based on the information available to us, we were able to confirm the event.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.One used catheter was received at the manufacturing site for investigation.The sample was inspected, and the catheter showed a leak due to a hole on the extension tube.The manufacturing process was reviewed and no manufacturing related causes contributing to the reported condition were found.Controls are in place to prevent the reported condition from occurring.Based on all available information, the catheter was in good conditions prior to use and a leak was not detected during flushing.The issue was only detected when the device was in use with the patient.The most probable root cause was determined to be misuse.A corrective action is not applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures.All information received will be used for further tracking and trending purposes.

• Brand Name: 1.9F ARGYLE SINGLE LUMEN PICC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02864
• 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: 16236145
• MDR Text Key: 308356821
• Report Number: 3009211636-2023-00805
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 10884527004645
• UDI-Public: 10884527004645
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/08/2023

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 Operator: Health Professional
• Device Model Number: 43303
• Device Catalogue Number: 43303
• Device Lot Number: 1930300072
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2023
• Initial Date FDA Received: 01/24/2023
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 03/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 2 KG