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 Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Renal Impairment (4499)
Date of Event	11/08/2020
Type of Reportable Event	Death
Event or Problem Description
The customer reported that at 20:30 on (b)(6) 2020 they were notified that an infant's picc line was leaking.It was determined that the catheter itself was leaking necessitating removal.The registered nurse then mentioned that they thought the line may have been leaking the night before but were unsure if it was iv fluid or urine in the bed.The infant had almost no urine output throughout the day on (b)(6) 2020 and had increased bun and creatinine.It seems likely that the male patient received some but certainly not all of the fluid that he should have in the past 24 hours resulting in anuria and poor renal perfusion.Additional information received on 31jul2023 stated that the patient required fluid resuscitation including a fluid bolus and increasing his total fluid volume for the day.The patient passed away the day after the picc was found to be leaking.Cause of death was undetermined in the chart.He was born extremely premature.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
A sample was not received for the investigation.A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported issue and determine the root cause, therefore a corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.If a sample is received at a later date, this complaint will be reopened for further investigation.This complaint will be used for 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 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: 17452272
• Report Number: 3009211636-2023-00823
• Device Sequence Number: 17983633
• Product Code: LJS
• UDI-Device Identifier: 10884527004645
• UDI-Public: 10884527004645
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 43303
• Device Catalogue Number: 43303
• 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: 07/26/2023
• Supplement Date Received by Manufacturer: 07/26/2023
• Initial Report FDA Received Date: 08/03/2023
• Supplement Report FDA Received Date: 09/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Male