MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 22 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 06/18/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reez3412 showed four similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in the netherlands.

Event Description

It was reported by healthcare professional "we have been using your product, the powerglide pro midline catheter, for a year now.This is used for the administration of intravenous medication/fluid/blood collection.Only products suitable for peripheral administration are used for the application.In the last few months, we have had more than five incidents in a short period of time in patients who received a powerglide pro.We have seen a remarkable amount of thrombosis here after only a few days.This has all been demonstrated by ultrasound duplex in radiology.It is striking that the thrombosis can be seen over a distance of 10 cm (= length of the powerglide pro cannula).Because of the thrombosis caused by the powerglide, these patients are now temporarily bound to the use of blood thinners.All powerglides are ultrasound guided.The vein diameter was measured before insertion, with the vene ratio 1:3 being maintained (max.1/3 of the vessel is filled with cannula).The insertion site differed: in the forearm and upper arm." this report addresses the third of five devices.

• Brand Name: 22 GAUGE POWERGLIDE PRO MIDLINE CATHETER 8CM BASIC KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12166303
• MDR Text Key: 261474538
• Report Number: 3006260740-2021-02711
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6F122080
• Device Lot Number: REEZ3412
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other