MAUDE Adverse Event Report: BARD ACCESS SYSTEMS, INC. PERIPHERAL CATHETER INSERTION KIT 20G X 2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number AC0202252

Device Problems Entrapment of Device (1212); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2021

Event Type  malfunction  

Event Description

Rn was inserting an accucath and had trouble threading the catheter.When rn removed the device and retracted the needle, the guidewire had a plastic piece of the catheter stuck to it and was filled with blood.This did not result in a retained foreign body.No harm to the patient.Manufacturer response for catheter,intravascular,therapeutic,short-term less than 30 days, peripheral catheter insertion kit.Awaiting response.

• Brand Name: PERIPHERAL CATHETER INSERTION KIT 20G X 2.25
• 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: 12420949
• MDR Text Key: 269771796
• Report Number: 12420949
• 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
• Type of Report: Initial
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AC0202252
• Device Catalogue Number: AC0202252
• Device Lot Number: REFQ1165
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28470 DA
• Patient Weight: 66