MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC CATHETER (5F) (DUAL-LUMEN) (55CM); PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Catalog Number	CK000553
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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, at this time, for evaluation.A lot history review (lhr) of rezh2095 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
On 08/22/2016- per sales representative, facility reported that a patient had a bard picc placed at a different facility.It was stated that the picc leaked in the bicep during diagnostic studies for stress test.The picc was removed in invasive radiology.

• Brand Name: POWERPICC CATHETER (5F) (DUAL-LUMEN) (55CM)
• 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: 5947547
• Report Number: 3006260740-2016-00479
• Device Sequence Number: 839823
• Product Code: LJS
• UDI-Device Identifier: 00801741107474
• UDI-Public: (01)00801741107474(17)170228(10)REZH2095
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/22/2016

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: 02/28/2017
• Device Catalogue Number: CK000553
• Device Lot Number: REZH2095
• 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: 09/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1