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

Model Number AC0202250

Device Problems Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/01/2021

Event Type  malfunction  

Event Description

I attempted to place piv (peripheral intravenous line) with ultrasound guidance and 20g 2.25 inch accucath iv.After cannulating the vein, i attempted to retract guidewire and met resistance.I was also unable to activate the safety.I removed the iv and the needle and cath seemed intact, but the guidewire seemed to be missing the end.I notified physician and x-ray was ordered, confirming retained material in the r ac.Bard accucath intravascular catheter 20g 2.25in ref (b)(4).Lot #: q1275.Expiration date: 2022-07-31.Rn (registered nurse) was inserting an iv via ultrasound.No issues upon insertion.Upon attempts to retract wire rn met resistance.Rn attempted to loosen wire without success.Rn could not disengage needle.Rn withdrew device to find that guide wire was not intact.Imaging demonstrates small piece retained.Patient returned to ed (emergency department) for nausea and vomiting (unrelated to rfo [retained foreign object]).Repeat arm x-ray completed-documentation demonstrates rfo remains in place.Documented as being in soft tissue.Bard rep on site at the time.

• Brand Name: ACCUCATH PERIPHERAL CATHETER INSERTION KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS, INC.; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 13224055
• MDR Text Key: 283610620
• Report Number: 13224055
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AC0202250
• Device Catalogue Number: AC0202250
• Device Lot Number: Q1275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/05/2022
• Event Location: Hospital
• Date Report to Manufacturer: 01/11/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20440 DA
• Patient Sex: Female