MAUDE Adverse Event Report: CARDINAL HEALTH 5.0FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160341

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

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

Event Date 03/08/2022

Event Type  malfunction  

Event Description

The customer reported that the catheter had a crack in the line.No injury but the neonate did have some loss of blood.Additional information received on 14-mar-2022 stated that the crack was noticed just below the hub where the catheter is joined causing the device to leak.The device was inserted on (b)(6) 2022.The area was cleaned with betadine prior to insertion.The device was not difficult to handle during insertion and it was not difficult to secure, secured with a suture and then goal post-taping.The line was flushed with 0.9 nacl and a 5ml syringe prior to insertion and at least three more times with no fluid leak noted.When blood was drawn back from the line for lab work several hours after insertion blood was noted leaking from the crack.Alcohol was used to clean the hub prior to blood draw.Amount of blood loss was a minimal amount, the patient did not experience any clinical symptoms due to this issue.A new 5f single luman uac was placed immediately following the removal of the cracked line.No additional intervention or treatment required.The patient's current status is unknown as the infant was transferred for higher level of care.

Manufacturer Narrative

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

Manufacturer Narrative

A device history review (dhr) for lot number 1929600268 item 8888160341 was performed and it revealed no discrepancies that may have contributed to the reported issue.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical, and dimensional evaluation results indicated that the product met specification requirements.In addition, all dhrs are reviewed for accuracy prior to product release.A physical sample for this complaint was not returned for evaluation.However, two photos were provided as evidence.After a visual inspection of the provided photos the reported issue was unable to be confirmed as the photos did not show the issue reported.Therefore, it is not possible to confirm the reported condition or determine a root cause based on the available information.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100% in process visual inspection and visual acceptance sampling are performed in the plant) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.

• Brand Name: 5.0FR URETHANE UMB CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): CARDINAL HEALTH; edificio b20 calle #2 zona fra; alajuela ; CS
• 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: 13758662
• MDR Text Key: 287123371
• Report Number: 3009211636-2022-00777
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005120
• UDI-Public: 20884527005120
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888160341
• Device Catalogue Number: 8888160341
• Device Lot Number: 1929600268
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2022
• 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 Age: 1 DA
• Patient Weight: 3 KG
• Patient Race: White