MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE; 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 Problems Pain (1994); Numbness (2415); Swelling/ Edema (4577)

Event Date 06/02/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported via ms&s "patient states she had powerglide pro midline placed on (b)(6) 2018 and the facility never removed it.She still has it and wants to know when should it be removed." ms&s "informed that the powerglide pro is a midline catheter and the recommendation is to remove it at least every 29 days.Asked patient if she is sure she still has the catheter (can she see it on the outside of her arm).She stated no does not see it, but she has had a swelling to the "middle of her arm" since she left the hospital.She has pain also all the way up her arm.She reports having shown and spoken to several hcps about it and was given different possible causes.No tests have been performed to assess the site.She stated that she is going to see a neurologist on (b)(6).I recommended she speak with them about performing some kind of test to assess the site.Patient does not have any product code or lot number for the device.She also does not have access to the internet or email.Add info rcvd 06/07/2021 - "spoke to customer on the phone: customer stated she has to go see a neuro surgeon again, because she has nothing but trouble ever since she has the product , she doesn't have real usage of the arm again, she is going to see a neuro surgeon on thursday (b)(6) 2021.To discuss surgery with the doctor.Her arm swells up a couple inches than the right, her hand does not go up.Ever since she had the stupid bard product put in, she has had trouble since.Nobody gave her information about the product and she wants information of what went into her arm, her arm hurts all the time and she cries all the time, she can't even hold a cell phone.She is going to have a nurse do a bunch of test in her arm, and she was advised that she may be having another neuro surgery again.Catheter was removed 2 or 3 yrs ago and she has had trouble with the arm ever since.10cm is the size of the product, the top of the arm is ridged like a mountain , like when you wear a tight shirt, the shirt is ridged and there is another ridge, it is not soft, it is hard and it hurts.Customer stated she can't lift a 1/2 gallon of water, and her arm is going numb.Symptoms began right after it was inserted, and she told the nurse, and the nurse advised it will go down.Customer read out what the paper she had listed "all is says is powerglide pro midline catheter, it says not a central line, indicated for up to 29days of infusion therapy, power injectable, date it was inserted is 2018, so it was three years ago (b)(6) 2018.Insertion site l' cephalic catheter line contains 10cm, 0739259/1509r.Underneath the paper it states, therapies not appropriate for midline catheters include both therapies requiring central venous access.Refer to standard of practice and institutional policies.They put this in my arm and it is not supposed to be in my arm.Customer advised she is taking the paper work to her neurosurgeon, as when they put in the product she thought that she was going to die.".

• Brand Name: POWERGLIDE PRO MIDLINE
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12061390
• MDR Text Key: 258354664
• Report Number: 3006260740-2021-02450
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention