MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	AC0202250
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2021
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 reeu1917 showed three other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.
Event or Problem Description
It was reported two insertions were successful, blood return, etc., with our primary iv team and within about 4 hours the iv won¿t flush.When removing the catheters there are not any kinks or bends and the lumens will not flush even after removal from the patient.Additional information provided 03/04/2021: it was reported the catheters placed quit working within 6 hours of placement, with blood return and flush being able to be completed upon insertion.When removed the catheter was not kinked or bent in anyway and would not flush at all after removal even with no evidence of occlusion in catheter tip.It was reported this occurred with two devices.This report addresses the second device.

• Brand Name: ACCUCATH INTRAVASCULAR CATHETER 20 GX2.25
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11576716
• Report Number: 3006260740-2021-01003
• Device Sequence Number: 14317859
• Product Code: FOZ
• UDI-Device Identifier: 00801741110948
• UDI-Public: (01)00801741110948
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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 Model Number: AC0202250
• Device Catalogue Number: AC0202250
• Device Lot Number: REEU1917
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/04/2021
• Initial Report FDA Received Date: 03/26/2021
• 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: Other