MAUDE Adverse Event Report: COVIDIEN 3.5FR URETHANE UMB CATH; CATHETER, UMBILICAL ARTERY

Model Number 8888160333

Device Problems Material Too Rigid or Stiff (1544); Material Split, Cut or Torn (4008)

Patient Problem Blood Loss (2597)

Event Date 02/25/2020

Event Type  Injury  

Event Description

The customer reported that the staff was loosening some sutures to remove the umbilical arterial line, but blood started coming out.While pulling the line out, it snapped in half.They grabbed the end of the line before it went into the baby and was able to remove the entire line.It was noted the piece that was inside the baby was stiffer than the rest of the line.Additional information was received from the customer stating that there was approximately 20 ml of blood loss.Prbc transfusion 30mls/kg was required for additional treatment.The baby is currently doing well.

Manufacturer Narrative

H 3: evaluation summary: a device history record (dhr) review revealed no discrepancies that may have contributed to a complaint of this failure mode.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.One catheter was received for analysis and investigation.Visual inspection of the sample showed signs of use.The catheter showed a clean cut at the end, and it seems to be manipulated.The event reported was confirmed.An ishikawa diagram was used to determine the potential causes for this event.It is important to consider that the instructions for use warn to exercise caution when using sharp instruments near the catheter.It warns to not use instruments with sharp or rough edges directly on the catheter since even a minor cut could break the catheter.Based on the available information this potential cause could not be discarded.100% of the catheters are submitted to a pressure testing.The cuts or damage of the catheter that was found during sample evaluation would be detected in this step.The most probable root cause can be considered as damage likely caused during use, due to manipulation.This complaint has not been confirmed as a manufacturing related issue.No trends or triggers have been found; therefore, a corrective and preventive action (capa) is not deemed necessary at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 3.5FR URETHANE UMB CATH
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 9772161
• MDR Text Key: 188819936
• Report Number: 3009211636-2020-00689
• Device Sequence Number: 1
• Product Code: FOS
• UDI-Device Identifier: 20884527005113
• UDI-Public: 20884527005113
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 1921900150
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/26/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other