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

Model Number AC1202250

Device Problems Difficult to Remove (1528); Difficult to Advance (2920); Separation Problem (4043)

Patient Problems Laceration(s) (1946); Foreign Body In Patient (2687)

Event Date 11/04/2021

Event Type  malfunction  

Event Description

Nurse inserting us guided iv: accucath guide wire tip sheer off in a patient's arm requiring vascular to come in.Once i was in vein, i advanced the guide wire.I met resistance and retracted the guidewire and aborted iv attempt at that time.I could not retract needle despite it appearing that guidewire was completely retracted.(slide did feel "gritty") placed us probe to arm to locate another site and saw glowing.Checked catheter and found coiled part of guidewire missing.Immediately pulled physician to bedside.Vascular consulted for retained foreign body - to or for removal with mac tiva anesthesia.

• Brand Name: ACCUCATH ACE
• 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: 13009834
• MDR Text Key: 282275603
• Report Number: 13009834
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741137952
• UDI-Public: (01)00801741137952
• 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: 11/10/2021,11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AC1202250
• Device Catalogue Number: AC1202250
• Device Lot Number: REFT0826
• 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: 11/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19710 DA
• Patient Sex: Female
• Patient Weight: 100 KG