MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25

Model Number	AC0201250
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/10/2017
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 rebv0152 showed five other similar product complaints from this lot number.Device not returned yet.
Event or Problem Description
It was reported by the facility, that the healthcare professional was performing a training with the device.When the cap was removed the catheter pulled out and remained inside the cap.Device was not used on patient.This file addresses device two of five.
Additional Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.Upon receiving additional information about the event, it was determined that a reportable event had not occurred.A lot history review (lhr) of rebv0152 showed five other similar product complaints from this lot number.Device not returned yet.
Event or Problem Description
It was reported by the facility, that the healthcare professional was performing a training with the device.When the cap was removed the catheter pulled out and remained inside the cap.Device was not used on patient.This file addresses device two of five.

• Brand Name: ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7068377
• Report Number: 3006260740-2017-02138
• Device Sequence Number: 1119045
• Product Code: FOZ
• UDI-Device Identifier: 00801741110917
• UDI-Public: (01)00801741110917
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2018

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 Model Number: AC0201250
• Device Catalogue Number: AC0201250
• Device Lot Number: REBV0152
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1