MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 20GA, ACCUCATH IV CATHETER, 1.25", BASIC; INTRAVASCULAR CATHETER

Model Number	AC0201250
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebp1306 showed no other similar product complaint(s) from this lot number.Device not yet returned.
Event or Problem Description
It was reported by the facility, via the sales rep, that the nurse was consulted for a patient that needed iv access.The patient had already been seen by the day shift and had an accucath placed.When the nurse talked to a second nurse he reported to her that the hub of the accucath broke away from the catheter.The catheter was still in the patient's arm with blood spewing out, per the bedside nurse.The catheter was removed by the nurse in its entirety.The nurse reported that when she entered the patient's room, the hub was till connected to the iv tubing.A second file was opened, as another accucath was placed.

• Brand Name: 20GA, ACCUCATH IV CATHETER, 1.25", BASIC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6765568
• Report Number: 3006260740-2017-01212
• Device Sequence Number: 2013889
• Product Code: FOZ
• UDI-Device Identifier: 00801741110917
• UDI-Public: (01)00801741110917
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2018
• Device Model Number: AC0201250
• Device Catalogue Number: AC0201250
• Device Lot Number: REBP1306
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1