MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, 18GX1.25 BASIC; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Material Frayed (1262)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/06/2019

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recz1908 showed no other similar product complaint(s) from this lot number.Mw5091755.

Event Description

It was reported via received medwatch " patient had retained guide wire in the right forearm after insertion of the iv".No other information was provided.

• Brand Name: ACCUCATH, 18GX1.25 BASIC
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: kayla olsen ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225010
• MDR Report Key: 9679565
• MDR Text Key: 178108760
• Report Number: 3006260740-2020-00415
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741110900
• UDI-Public: (01)00801741110900
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2019,02/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: AC0181250
• Device Lot Number: RECZ1908
• 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: 12/12/2019
• Distributor Facility Aware Date: 12/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2020
• Date Manufacturer Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 21