MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BASIC KIT 18G X 10 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 redr3236 showed one other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that "the guidewire was checked prior to deployment.Normal access steps taken, venipuncture made.Advanced guidewire, no resistance.Advanced catheter- met positive resistance, so retracted the catheter by pulling back on the wings at that point.Attempted to retract gw and met positive resistance.Patient complained of pain.On palpation over site felt lumpy.Pulled device out under fluoroscopy and frayed pglide wire noted.Patient did not experience any more complaints or issues after device removed.X-ray noted all device remnants removed.Rapid response noted.".

• Brand Name: BASIC KIT 18G X 10 CM WITH BIOPATCH
• 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: 9195149
• Report Number: 3006260740-2019-03035
• Device Sequence Number: 16781453
• Product Code: FOZ
• UDI-Device Identifier: 00801741140518
• UDI-Public: (01)00801741140518
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: N/A
• Device Catalogue Number: F318107T
• Device Lot Number: REDR3236
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2019
• Initial Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1