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

Catalog Number F122088PT

Patient Problems Needle Stick/Puncture (2462); Device Embedded In Tissue or Plaque (3165)

Event Date 02/13/2024

Event Type  Injury  

Event Description

Description of complaint: it was reported by customer that on (b)(6) 2024.An experience power glide midline nurse was placing a 22 gauge 8 cm (lot number rejn2430) ast midline into a patient's right basilic vein.He had the needle inside the vein the of the angle of the device was low.The nurse was able to push the guidewire in with one smooth motion.He slide the catheter down into the patient's arm with ease.Upon pulling the needle/guidewire out, the catheter sheared apart about 5mms below the hub of the midline.The rest of the catheter was balled up on the guidewire under the patient's skin.We had to do a small incision in the arm so we could grab the catheter with the guidewire.To ensure that it wouldn't get lost in the patient.This was witnessed by two healthcare employees trained in midlines.For lot number.Item#f122088pt  lot#rejn2430.No foreign object of catheter fragment noted with xray result.Have product and pictures but this program will not accept in pdf format.

• Brand Name: POWERGLIDE PRO MIDLINE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.
• MDR Report Key: 18809421
• MDR Text Key: 336686660
• Report Number: MW5152150
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140594
• UDI-Public: (01)00801741140594(17)250228(10)REJN2430
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: F122088PT
• Device Lot Number: REJN2430
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 MO
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White