MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, 18 GX2.25; INTRAVASCULAR CATHETER

Model Number AC0182250

Device Problems Disconnection (1171); Device Dislodged or Dislocated (2923)

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

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 for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rebv1051 showed four other similar product complaint(s) from this lot number.The complaints for this lot number (rebv1051) have been reported from the same facility.

Event Description

Bard clinical specialist reported that during demonstration of the product the catheter disconnected from the hub.It was stated that the hub remained within the device and the needle and catheter disconnected.The devices were not used on patients and were discarded.On (b)(6) 2017 sales rep reported event occurred when removing protective sleeve.Sales rep stated that the catheter appeared to be adhered to the inside of the protective sleeve.Sales rep attempted to remove catheter from sleeve but required use of a needle to dislodge.Sales rep did not feel the catheter broke and did not see any catheter remnants on the device.This file addresses device 2 of 5.

Manufacturer Narrative

A lot history review (lhr) of rebv1051 showed four other similar product complaint(s) from this lot number.The complaints for this lot number (rebv1051) have been reported from the same facility.

Event Description

Bard clinical specialist reported that during demonstration of the product the catheter disconnected from the hub.It was stated that the hub remained within the device and the needle and catheter disconnected.The devices were not used on patients and were discarded.10/16/2017-sales rep reported event occurred when removing protective sleeve.Sales rep stated that the catheter appeared to be adhered to the inside of the protective sleeve.Sales rep attempted to remove catheter from sleeve but required use of a needle to dislodge.Sales rep did not feel the catheter broke and did not see any catheter remnants on the device.This file addresses device 2 of 5.

• Brand Name: ACCUCATH, 18 GX2.25
• 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: shauna nielson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225536
• MDR Report Key: 6974842
• MDR Text Key: 90904843
• Report Number: 3006260740-2017-01893
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: AC0182250
• Device Catalogue Number: AC0182250
• Device Lot Number: REBV1051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/24/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2017
• 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