MAUDE Adverse Event Report: C.R. BARD, INC. POWERGLIDE PRO MIDLINE CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number F322087T

Patient Problems Failure of Implant (1924); Foreign Body In Patient (2687)

Event Date 07/22/2023

Event Type  Injury  

Event Description

Was placing a 22g x 8cm powerglide pro midline catheter in the left forearm using ultrasound guidance.Once in the vein wire threaded in with no issues, attempted to thread in catheter and met resistance about 1/3 of the way in.Assessed that the needle was still in the vein but catheter would not advance the catheter was attempted to be retracted back on the needle.Resistance felt and had to retract catheter, needle and guidewire all together with moderate pressure to remove device.Once removed noticed that 2/3 of the catheter was retained in the patient.Patient was taken to surgery and a vascular surgeon removed the retained catheter.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 17425014
• MDR Text Key: 320197939
• Report Number: MW5120354
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: F322087T
• Device Lot Number: REGZ2723
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2023
• Patient Sequence Number: 1
• Treatment: HARRINGTON RODS.; IN THE HOSPITAL : DULCOLAX.; IN THE HOSPITAL : MORPHINE.; IN THE HOSPITAL: COLACE.; IN THE HOSPITAL: FERROUS SULFATE.; IN THE HOSPITAL: FOLIC ACID.; IN THE HOSPITAL: LACTATED RINGER'S SOLUTION.; IN THE HOSPITAL: LOVENOX.; IN THE HOSPITAL: MAGNESIUM OXIDE.; IN THE HOSPITAL: MELATONIN.; IN THE HOSPITAL: MIDODRINE.; IN THE HOSPITAL: MILK OF MAGNESIA.; IN THE HOSPITAL: MIRALAX.; IN THE HOSPITAL: MYLICON.; IN THE HOSPITAL: NORCO.; IN THE HOSPITAL: NORMAL SALINE FLUSHES.; IN THE HOSPITAL: PROTONIX.; IN THE HOSPITAL: ROCEPHIN.; IN THE HOSPITAL: SENOKOT-S.; IN THE HOSPITAL: TRAMADOL.; USES LEG BRACES AND FOREARM CRUTCHES TO GET AROUND.
• Patient Outcome(s): Hospitalization
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 44 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White