MAUDE Adverse Event Report: BARD ACCESS SYSTEMS ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	AC0201250
Health Effect - Clinical Code	Infiltration into Tissue (1931)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of recn0300 showed two other similar product complaint(s) from this lot number.All three complaints for this lot number recn0300 have been reported from the same facility.
Event or Problem Description
It was reported that: "catheter inserted in ac space of the arm, flushed easily and had reliable blood return, patient received a ct scan with power contrast at 300 psi and 3.2 ml/sec and part of the injection was successful and but a significant amount of the contrast was injected outside of the vein and caused an infiltration.Test was still successful.We speculated that not much of the catheter was in the vein and the pressure from the contrast injection forced the catheter back and off of the vessel." no patient injury reported.

• Brand Name: ACCUCATH, INTRAVASCULAR CATHETER 20 GX1.25
• 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: 7357768
• Report Number: 3006260740-2018-00474
• Device Sequence Number: 2156143
• Product Code: FOZ
• UDI-Device Identifier: 00801741110917
• UDI-Public: (01)00801741110917
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/21/2018

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: AC0201250
• Device Catalogue Number: AC0201250
• Device Lot Number: RECN0300
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1