MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC / TELEFLEX, INC TELEFLEX TRIPLE LUMEN CATHETER CENTRAL LINE; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 05/22/2020

Event Type  Death  

Event Description

Pt was two days post cabg when he suffered a cardiac arrest after a blood transfusion.During cpr, it was noted that his triple lumen catheter had become un-attached and one of the pots was broken away from the hub - leaving the port open to air.During investigation, it was noted that the plastic "tail" broke loose from the blue plastic hub (connection).There did not appear to be a cut or tear in the actual tubing, it appeared to have separated at the point of attachment where it is glued into the hub.Fda safety report id# (b)(4).

• Brand Name: TELEFLEX TRIPLE LUMEN CATHETER CENTRAL LINE
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC / TELEFLEX, INC; morrisville NC 27560
• MDR Report Key: 10520607
• MDR Text Key: 206757773
• Report Number: MW5096534
• Device Sequence Number: 1
• Product Code: FOZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 69 YR