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

Model Number	N/A
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The information provided by bd represents all of the known information at this time.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 recq0401 showed one other similar product complaint (s) from this lot number.
Event or Problem Description
It was reported that when placing an 18g 1.25 inch accucath catheter with ultrasound guidance, the blood return was good, but the guidewire would not thread.The guidewire was retracted and repositioned several times and eventually thread through for a successful iv placement.It was observed that the tip of the guidewire appeared to be altered after removal and a right arm x-ray was ordered.It was stated the patient was taken to surgery and the iv was used without any problems.The radiologist stated there was a thin line on the x-ray, but could not confirm if it was a piece of wire or not.The ir np stated that it was too small to retrieve if it is wire and the iv was removed without incident.It was reported that the area was without any swelling, redness, or tenderness.The wire could not be palpated and the patient was discharged without any apparent harm.

• 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: 8189465
• Report Number: 3006260740-2018-03643
• Device Sequence Number: 13982865
• Product Code: FOZ
• UDI-Device Identifier: 00801741110900
• UDI-Public: (01)00801741110900
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K153298
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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 Model Number: N/A
• Device Catalogue Number: AC0181250
• Device Lot Number: RECQ0401
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/21/2018
• 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: Hospitalization