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

Model Number	F120101
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/14/2017
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 reaz0439 showed no other similar product complaint(s) from this lot number.The device has not been returned to the manufacturer for evaluation.
Event or Problem Description
It was reported by the facility, via the sales rep, that they had a midline with a jagged wire, it was identified before they attempted to place it.On 07/17/17 additional information received from facility: the nurse stated that she could describe that the wire tip was bent in almost a 90 degree "jagged" angle.

• Brand Name: DOT PFLEX, 20G 10CM FULL (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: 6769470
• Report Number: 3006260740-2017-01240
• Device Sequence Number: 132467
• Product Code: FOZ
• UDI-Device Identifier: 00801741110580
• UDI-Public: (01)00801741110580
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/04/2017

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: 05/31/2018
• Device Model Number: F120101
• Device Catalogue Number: F120101
• Device Lot Number: REAZ0439
• 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: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1