MAUDE Adverse Event Report: CARDINAL HEALTH 3.5FR DUAL-LUMEN UVC CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160531

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/09/2022

Event Type  Injury  

Event Description

The customer reported that at the beginning of planned removal of the uac (umbilical artery catheter), the resident tried to visualize the ua (umbilical artery).They did not use scissors but did manipulate the line with tweezers.Blood began oozing from the site, gauze and pressure was held to try to control the bleeding.The patient was bleeding through multiple pieces of gauze and the fellow was called to bedside.Surgicell was brought to the bedside and applied to the site and the bleeding eventually stopped.The patient had 15ml of blood loss.Later a rbc (red blood count) was ordered to replace blood loss.The patient was noted to be oozing blood at the uvc site within 15 minutes of blood product running.The entire pediatric team was at their bedside and the np (nurse practitioner) noticed a crack in uvc (umbilical venous catheter).The uvc was pulled and two pivs (peripheral intravenous line) were placed for access and emergent picc (peripherally inserted central catheter).The event required addition patient monitoring.Per additional information received on 29apr2022, the issue with the catheter occurred somewhere on the catheters body.The area was cleaned with betadine, the hub was cleaned with alcohol and the area was completely dried prior to insertion.The catheter was not difficult to handle or secure during insertion and was secured with a bridge.It was inserted in the umbilicus on (b)(6) 2022 and removed on (b)(6) 2022.Tpn/lipids/dopamine (continuous), ampicillin (intermittent), gentamicin (intermittent) and caffeine (intermittent) was infusing through the catheter.2 units of rbcs (9ml and 6 ml respectively) were given.The hgb/hct pre transfusion was hgb 6.2 , hct 17 and post transfusion was hgb 9.4 , hct 28.The patient experienced hemodynamic instability and a blood transfusion was required.The patient is currently stable but critical/ill due to prematurity.

Manufacturer Narrative

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

Manufacturer Narrative

The item code was originally reported as 8888160333 which is a single lumen catheter.The customer confirmed the item code to be 8888160531 which is a double lumen catheter.Therefore, sections d1 and d4 have been updated.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.However, as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.One used catheter from an unknown lot number was received at the manufacturing site inside of a generic plastic bag.A visual inspection revealed that the sample came with two end caps that do not belong to the original product and blood residue inside of the device.Upon physical evaluation, the reported issue was confirmed.There were no manufacturing related root causes identified during the investigation.Per details provided, the catheter was used for six days before the reported issue occurred indicating that the catheter was in good condition prior to use and leaking was not detected during flushing or use of the device.The reported issue was observed after 7 days when removing the device from the patient.During sample evaluation, the reported condition was replicated by using a sharp object on a representative sample.It should be noted that not following the instructions for use correctly could contribute to catheter damage during use.Per the instructions for use the catheter may be grasped with smooth forceps or fingertips and alcohol should not be used on the device as it can cause the polyurethane to leak or break.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.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.This complaint will be used for tracking and trending purposes.

• Brand Name: 3.5FR DUAL-LUMEN UVC 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: 14378601
• MDR Text Key: 293610319
• Report Number: 3009211636-2022-00787
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005175
• UDI-Public: 20884527005175
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2022

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: 8888160531
• Device Catalogue Number: 8888160531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/12/2022
• Supplement Dates Manufacturer Received: 04/19/2022; 04/19/2022
• Supplement Dates FDA Received: 05/20/2022; 06/07/2022
• 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