MAUDE Adverse Event Report: CARDINAL HEALTH UMBILICAL CATHETER SNGL LUMEN 3.5FR; CATHETER, UMBILICAL ARTERY

Model Number 8888160333

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/30/2022

Event Type  Injury  

Event Description

The customer reported that on (b)(6) 2022, a three-day old newborn with a weight of 2865 grams required an exchange transfusion due to high jaundice value, so an umbilical artery catheter (3.5fr.) was placed.The placement process went smoothly.After the x-rays were taken, it was found that the umbilical vein catheter was too deep and had to be pulled out.However, the doctor caused the catheter to rupture during the removal process, leaving 10 cm in the patient's body.Finally, the pediatric surgeon entered the operating room and removed the breakage catheter which remained inside patient body, by cut down catheter.Additional information was received and stated that the patient received additional surgical procedure/intervention to remove the affected product from patient body and the patient is still on hospitalization for monitoring.Per customer, they don't have more detailed information about what procedure code applied to this case and the physician reluctant to discuss more about this case.

Manufacturer Narrative

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

Manufacturer Narrative

The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.One used catheter was received inside a generic plastic bag for the evaluation.Upon visual evaluation, the same has residues of blood and it was observed that the catheter tube was broken near 10cm mark.Therefore, the event reported was confirmed.Based on the investigation performed and information provided it was determined that the catheter was in good conditions prior to use and that not following the instructions correctly could contribute to catheter damage during use since no manufacturing related potential cause was identified during sample evaluation.At this time, a corrective and preventive action is not deemed necessary.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: UMBILICAL CATHETER SNGL LUMEN 3.5FR
• Type of Device: CATHETER, UMBILICAL ARTERY
• 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: 15633691
• MDR Text Key: 302026304
• Report Number: 3009211636-2022-00799
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 10884527005116
• UDI-Public: 10884527005116
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 2104700148
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2022
• 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 Outcome(s): Other; Hospitalization