MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PFLEX, 20G 10CM FULL W/O GIVA (POWERGLIDE PRO); INTRAVASCULAR CATHETER

Model Number	F220101
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/03/2017
Type of Reportable Event	Serious Injury
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, at this time, for evaluation.A lot history review (lhr) of rebs2358 showed no other similar product complaint(s) from this lot number.Device not returned, at this time.
Event or Problem Description
It was reported by the sales rep that the nurse inserted the midline in the left upper arm of the patient, the patient began complaining of pain so the nurse tried to remove the device without success.A second member of their team attempted to remove the device was unsuccessful.Interventional radiology had to remove the device.The device was successfully removed and secured.No patient injury was reported.

• Brand Name: DOT PFLEX, 20G 10CM FULL W/O GIVA (POWERGLIDE PRO)
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6835060
• Report Number: 3006260740-2017-01466
• Device Sequence Number: 68150
• Product Code: FOZ
• UDI-Device Identifier: 00801741110689
• UDI-Public: (01)00801741110689
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/31/2017

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: F220101
• Device Catalogue Number: F220101
• Device Lot Number: REBS2358
• 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: 08/31/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1