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

Model Number F320088PT

Device Problems Break (1069); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/17/2022

Event Type  malfunction  

Event Description

Powerglide midline device came apart and upon removal of device the catheter broke off and was not intact.Possible piece broke off into patient's arm just beneath the skin.Sonogram revealed 0.3cm focal linear echogenicity without shadowing or double line structure of sub dermis without demonstrable vascularity.Physician progress note states retained partial iv catheter in right upper arm, visible on ultrasound, no intervention per ir (interventional radiology).Fda safety report id # (b)(4).

• Brand Name: BARD POWERGLIDE MIDLINE CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD/C.R. BARD, INC.
• MDR Report Key: 15322134
• MDR Text Key: 299004459
• Report Number: MW5111791
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F320088PT
• Device Catalogue Number: F320088PT
• Device Lot Number: REFZ3241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female