MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH ACE INTRAVASCULAR CATHETER 22GX1.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reep0966 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the coiled tip of the guidewire of the accucath had come undone at the hub of the catheter.Upon closer inspection the guidewire coil had hooked into the patients skin.Rn was able to aspirate and flush without difficulty prior to noticing the coiled tip.Rn also said the catheter upon removal showed kinks in several locations.The line had to be taken out and the patient received a second stick.

• Brand Name: ACCUCATH ACE INTRAVASCULAR CATHETER 22GX1.25
• 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: 10353309
• Report Number: 3006260740-2020-02754
• Device Sequence Number: 2329993
• Product Code: FOZ
• UDI-Device Identifier: 00801741137938
• UDI-Public: (01)00801741137938
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K162894
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2020

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: 04/30/2021
• Device Model Number: N/A
• Device Catalogue Number: AC1221250
• Device Lot Number: REEP0966
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1