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

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/06/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9679565
• Report Number: 3006260740-2020-00415
• Device Sequence Number: 17005611
• Product Code: FOZ
• UDI-Device Identifier: 00801741110900
• UDI-Public: (01)00801741110900
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2020
• Report Date (Section F): 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/06/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/17/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2020
• Initial Report FDA Received Date: 02/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 21
• Date Report Sent to FDA: 12/12/2019