MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 5F SINGLE-LUMEN CATHETER RADIOLOGY BASIC TRAY (70 CM NITONOL GUIDEWIRE; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	3175355
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/28/2016
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 was discarded after the event occurred.A lot history review (lhr) of reaq2482 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
As reported by the nurse via medwatch: a bard power picc 55 cm 5 french was placed via right cephalic.The picc was trimmed 10 cm and positioned at 42 cm mark.Chest x-ray taken on xxxx2016 showed appropriate position for picc tip.A thin metallic object approximately 3 cm at the level of the right axillary vein was noted by radiology on xxx2016.Interventional radiology consulted and retrieved the foreign object under fluoroscopy.Picture taken of the object by the radiologist was consistent with tip of stylet used with power picc.Fbo was not kept.".

• Brand Name: POWERPICC 5F SINGLE-LUMEN CATHETER RADIOLOGY BASIC TRAY (70 CM NITONOL GUIDEWIRE
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 5877521
• Report Number: 3006260740-2016-00420
• Device Sequence Number: 11073015
• Product Code: LJS
• UDI-Device Identifier: 00801741027703
• UDI-Public: (01)00801741027703(17)170928(10)REAQ2482
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K033389
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/28/2016
• Report Date (Section F): 07/01/2016

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: 09/28/2017
• Device Catalogue Number: 3175355
• Device Lot Number: REAQ2482
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/01/2016
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2016
• 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: 07/01/2016