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

Model Number	43303
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
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 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.
Additional 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
• Common Device Name: 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
• Report Number: 3009211636-2023-00805
• Device Sequence Number: 6521936
• Product Code: LJS
• UDI-Device Identifier: 10884527004645
• UDI-Public: 10884527004645
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 01/17/2023
• Initial Report FDA Received Date: 01/24/2023
• Supplement Report FDA Received Date: 03/08/2023
• 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: Female
• Patient Weight: 2 KG