ARROWGARD BLUE PLUS PRESSURE INJECTABLE TRIPLE LUMEN CVC KIT CDC-45703-P1A

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-27 for ARROWGARD BLUE PLUS PRESSURE INJECTABLE TRIPLE LUMEN CVC KIT CDC-45703-P1A manufactured by Teleflex Medical.

Event Text Entries

[185223727] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9888286
• MDR Report Key: 9888286
• Date Received: 2020-03-27
• Date of Report: 2020-03-11
• Date of Event: 2020-02-12
• Report Date: 2020-03-19
• Date Reported to FDA: 2020-03-19
• Date Reported to Mfgr: 2020-03-27
• Date Added to Maude: 2020-03-27
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ARROWGARD BLUE PLUS PRESSURE INJECTABLE TRIPLE LUMEN CVC KIT
• Generic Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Product Code: FOZ
• Date Received: 2020-03-27
• Catalog Number: CDC-45703-P1A
• Device Availability: *
• Device Age: 0 DA
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: TELEFLEX MEDICAL
• Manufacturer Address: 3015 CARRINGTON MILL BLVD MORRISVILLE NC 27560 US 27560

Patients

Patient Number	Treatment	Outcome	Date
1	0		2020-03-27