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

Model Number AC0182250

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2019

Event Type  malfunction  

Event Description

While nurse was withdrawing ultrasound guided iv #18 accucath angiocath from patient the very end of guidewire got stuck in superficial skin of patient.Guidewire was able to be released from patient's skin with little site trauma, unsure if any of the wire remained "inbedded" in patient.Patient unharmed by event.Catheter including guidewire and housing retrieved and placed in biohazard bag.Guidewire appears intact but with single coil as opposed to double coil at tip of guidewire.

• Brand Name: 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: 8343602
• MDR Text Key: 136276126
• Report Number: 8343602
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110931
• UDI-Public: (01)00801741110931
• 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: 02/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AC0182250
• Device Catalogue Number: AC0182250
• Device Lot Number: RECX2906
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2019
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 23360 DA
• Patient Weight: 115