MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERGLIDE PRO MIDLINE CATHETER (20G) (8CM); CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/18/2022

Event Type  Injury  

Event Description

It was reported by customer " i attempted to place a 20g 8cm bard power glide pro midline catheter.I used an ultrasound to assess the vessel and found the brachial vein to be appropriate for placement.I inserted the power glide and accessed the brachial vein, threaded the wire into the vessel, the wire went in smooth without resistance and the wire locked in place, i attempted to thread the catheter and met resistance.Procedure was stopped and the wire was removed without resistance.Attempted to remove catheter, felt resistance and stopped, attempted a second time to remove catheter and felt no resistance.Upon removal of the midline catheter i noticed it looked short and realized that the catheter was not intact.I used the ultrasound to scan the vessel and saw what appeared to be the catheter in the brachial vein.As of 0530 on 5/20 patient was waiting to see a vascular surgeon to determine next course of action to remove the piece of catheter." add info rcvd 06/02/2022: "the patient did have to have a procedure by the physician to have the missing piece removed under locate anesthetic.The explant date was on friday may 20th, there was no harm done to the patient".

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refz1243 showed no other similar product complaint(s) from this lot number.

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation:¿patient severity, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a catheter break is confirmed.Two 20 ga x 8 cm powerglide pro catheters and package label were returned for evaluation.The housings of the catheters were not returned.The first catheter length measured to be 8 cm in length.No apparent splits or breaks in the tubing were found.The second catheter measured contained a complete break and measured to be 4.1 cm in length.Microscopic observation of the split surface revealed it to initiate with a slanted with peak in a ¿<¿ shape.The initiation point was also found to be bulging outwards.The angle of the split and location of the damage is consistent with damage caused by the needle.This damage may occur if the needle is re-inserted after the catheter has been advanced.The product instructions for use (ifu) warns, ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ since a complete break in the catheter was found, the complaint is confirmed.

Event Description

It was reported by customer " i attempted to place a 20g 8cm bard power glide pro midline catheter.I used an ultrasound to assess the vessel and found the brachial vein to be appropriate for placement.I inserted the power glide and accessed the brachial vein, threaded the wire into the vessel, the wire went in smooth without resistance and the wire locked in place, i attempted to thread the catheter and met resistance.Procedure was stopped and the wire was removed without resistance.Attempted to remove catheter, felt resistance and stopped, attempted a second time to remove catheter and felt no resistance.Upon removal of the midline catheter i noticed it looked short and realized that the catheter was not intact.I used the ultrasound to scan the vessel and saw what appeared to be the catheter in the brachial vein.As of 0530 on (b)(6) patient was waiting to see a vascular surgeon to determine next course of action to remove the piece of catheter." add info rcvd 06/02/2022: "the patient did have to have a procedure by the physician to have the missing piece removed under locate anesthetic.The explant date was on friday(b)(6) there was no harm done to the patient" medwatch (b)(4) rcvd 06/21/2022: as the rrt vascular access specialist attempted to insert midline catheter she needed to remove catheter because she did not feel it was in the correct place, she felt resistance while trying to remove and stopped, attempted a second time to remove catheter and felt no resistance.Upon removal of the catheter she noticed it looked short and realized that the catheter was not intact.She used the ultrasound to scan the vessel and saw what she thought appeared to be the catheter in the brachial vein.A call was placed to vascular surgeon, while pressure was held above the site.The vascular surgeon instructed to cover the insertion site then apply a 3m¿ tegaderm¿ dressing on the insertion site.The patient did not appear to be in any distress during any of this.Patient had surgery the next day under local/iv sedation.In speaking with the vascular surgeon after the surgery, he was of the opinion that the catheter tip wasn't in the brachial vein but in the soft tissue.Device manufacturer would like the catheter so they can investigate.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER (20G) (8CM)
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14657418
• MDR Text Key: 295488905
• Report Number: 3006260740-2022-02229
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741142666
• UDI-Public: (01)00801741142666
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: F120080T
• Device Lot Number: REFZ1243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2021
• 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