MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. ACCUCATH INTRAVASCULAR CATHETER 18G; CATHETER, INTRAVASCULAR THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number 18GX2.25IN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 05/10/2019

Event Type  Injury  

Event Description

The catheter completely dislodged from the hub and remained in the pt's upper arm.Ultrasound scan did not pick up the dislodged catheter in the pt therefore the opacity of the catheter is questionable.The catheter had to be surgically removed.Fda safety report id# (b)(4).

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 18G
• Type of Device: CATHETER, INTRAVASCULAR THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC. ; salt lake city UT 84116
• MDR Report Key: 8615644
• MDR Text Key: 145373483
• Report Number: MW5086672
• 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: 05/14/2019

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 Model Number: 18GX2.25IN
• Device Catalogue Number: ACO182250
• Device Lot Number: RECU0738
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 142