MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT,PFLEX 18G 10CM FULL; INTRAVASCULAR CATHETER

Catalog Number	F118101
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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, as the device is being retained by the reporting facility.A lot history review (lhr) of reay1531 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported that while extracting the guidewire after insertion the staff noticed a fine piece of guidewire extruding from the open end of the midline.No patient injury was reported.

• Brand Name: DOT,PFLEX 18G 10CM FULL
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6425452
• Report Number: 3006260740-2017-00284
• Device Sequence Number: 511978
• Product Code: FOZ
• UDI-Device Identifier: 00801741110566
• UDI-Public: (01)00801741110566(17)180131(10)REAY1531
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/22/2017
• Report Date (Section F): 02/07/2017

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: 01/31/2018
• Device Catalogue Number: F118101
• Device Lot Number: REAY1531
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/07/2017