MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PG PRO 18G 8CM BASIC KIT; INTRAVASCULAR CATHETER

Model Number	F118080
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) of rebs0335 showed seven other similar product complaint(s) from this lot number.All complaints for this lot number (rebs0335) have been reported from the same facility.: samples were discarded.
Event or Problem Description
It was reported that the facility has had a total of 8 catheters not deploy properly and kink back on themselves under ultrasound, 180 degrees.There was no patient injury reported, but a delay in patient care as multiple attempts were made.Patient #2.

• Brand Name: PG PRO 18G 8CM BASIC KIT
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6848251
• Report Number: 3006260740-2017-01555
• Device Sequence Number: 19190207
• Product Code: FOZ
• UDI-Device Identifier: 00801741110504
• UDI-Public: (01)00801741110504
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 09/07/2017

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: 04/13/2019
• Device Model Number: F118080
• Device Catalogue Number: F118080
• Device Lot Number: REBS0335
• 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: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1