MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 20G X 8 CM WITH BIOPATCH; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	F320088T
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/05/2018
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 was discarded after the event occurred.A lot history review (lhr) of rebv1415 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported powerglide pro 8 cm 20 gauge catheter inserted into a patient.After vein accessed, the guidewire advanced with no problem, when the catheter advanced it only advanced halfway.Retracted the catheter and attempted to retract the guidewire but it was stuck in the advanced position.The entire midline pulled out of the patients skin and the guidewire had sheared, uncoiled, and the uncoiled portion was sticking out of the patient¿s skin.Sheared portion of the guidewire was then completely removed.There was no patient injury reported.

• Brand Name: FULL KIT 20G X 8 CM WITH BIOPATCH
• 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: 7469913
• Report Number: 3006260740-2018-00838
• Device Sequence Number: 13822152
• Product Code: FOZ
• UDI-Device Identifier: 00801741140723
• UDI-Public: (01)00801741140723
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• 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): 04/27/2018

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: F320088T
• Device Catalogue Number: F320088T
• Device Lot Number: REBV1415
• 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: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1