MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 18GA, ACCUCATH IV CATHETER, 2.25", BASIC; INTRAVASCULAR CATHETER

Model Number AC0182250

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2017

Event Type  malfunction  

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 rebv1051 showed three other similar product complaints from this lot number.Device, not yet returned.

Event Description

Facility reported to the sales rep that when the cap was removed from the accucath, the catheter remained stuck in the cap.It was not used on the patient.This file addresses the initial device.

Manufacturer Narrative

The information provided does not reasonably suggest the event may have caused or contributed to a death or serious injury of a patient, user or other person.If this event were to recur, it does not pose an incremental risk of harm to the patient, user, or other person because it renders the device unusable.Therefore this event is deemed not reportable per 21 cfr part 803.

Event Description

Facility reported to the sales rep that when the cap was removed from the accucath, the catheter remained stuck in the cap.It was not used on the patient.This file addresses the initial device.

• Brand Name: 18GA, ACCUCATH IV CATHETER, 2.25", BASIC
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7053894
• MDR Text Key: 93220358
• Report Number: 3006260740-2017-02102
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110931
• UDI-Public: (01)00801741110931
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153298
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Model Number: AC0182250
• Device Catalogue Number: AC0182250
• Device Lot Number: REBV1051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1