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 Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/20/2019

Event Type  malfunction  

Event Description

After catheter insertion, when the user was attempting to remove the guidewire, the guidewire "got stuck" in the patient's arm after the needle was retracted; the nurse pulled with minimal force on the guidewire and it came out; there was initially some concern for potential retained foreign body (rfb), but it was later determined by x-ray that there was no rfb present.Since the event, multiple ed staff members whom have been trained to use this device reported experiencing a similar issue with difficulty removing the guidewire after insertion of the catheter.Manufacturer response for peripheral intravenous catheter with guidewire - 20g, accucath (per site reporter).Manufacturer plans to provide additional training for ed staff who use this device.

• 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: 8757475
• MDR Text Key: 149928029
• Report Number: 8757475
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2019
• 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: RECN0847, RECX2134, REDN4132,
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2019
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1