MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT,PFLEX 20G 8CM FULL; INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/29/2016
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 for evaluation, as the device is being retained by the reporting facility.A lot history review (lhr) of reau1896 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by bas clinical specialist that she was at the facility training when the alleged failure occurred.While inserting the powerglide into the left brachial vein, the guidewire was inserted, the catheter was deployed, and when the housing unit was removed it was reported that the guidewire was sheared.Clinical specialist stated that the needle retracted into the safety device and the catheter was then removed.It was found under x-ray and ultrasound that a piece of the guidewire remained in the patient.Patient was sent to interventional radiology for removal.

• Brand Name: DOT,PFLEX 20G 8CM FULL
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6183552
• Report Number: 3006260740-2016-00689
• Device Sequence Number: 720894
• Product Code: FOZ
• UDI-Device Identifier: 00801741110672
• UDI-Public: (01)00801741110672(17)180131(10)REAU1896
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/01/2016

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: 01/31/2018
• Device Model Number: N/A
• Device Catalogue Number: F220081
• Device Lot Number: REAU1896
• 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: 12/16/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention