MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROWGARD BLUE PLUS PRESSURE INJECTABLE TRIPLE LUMEN CVC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number CDC-45703-P1A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/12/2020

Event Type  malfunction  

Event Description

Right intrajugular central line dislodged in ct scan when the patient was moved from cart to machine.The hub of the central line remained sutured in place (the catheter clamp and fastener were suture together into the patient's skin).It was discovered that the side wings of the anchoring device were not sutured/stapled.What did not happen in this case is that the anchoring device was not sutured to the patient's skin.It was reported that when the blue securement device is sutured in place, it may visibly hide or disrupt the view of the anchoring device, and resulting (as in this case), the md omitting to suture the anchor piece in place.The patient was on large amounts of pressors at the time and patient's blood pressure decreased to 49/43.Epinephrine was required and patient was given 20 gauge piv in order to maintain blood pressure.Follow up with providers who inserted the central line and neither believes the central line kits need to be changed at this time.The physician who inserted the line received feedback regarding central line insertion.The nursing role for dressing and securement dressings were appropriate for the patient's central line and placed per our procedure.Nursing recalled that this issue (not suturing the anchor device) has occurred previously by a few different providers.They question if there is a design issue that plays a role in this omission.

• Brand Name: ARROWGARD BLUE PLUS PRESSURE INJECTABLE TRIPLE LUMEN CVC KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 9888286
• MDR Text Key: 185223727
• Report Number: 9888286
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2020,03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: CDC-45703-P1A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/19/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2020
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24455 DA