MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 5 FR DL POWERPICC SOLO CATHETER, BASIC; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number	3295118
Health Effect - Clinical Codes	Swelling (2091); Discomfort (2330)
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, at this time, for evaluation.A lot history review (lhr) of rezl2475 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
It was reported on (b)(6) 2016 by the healthcare professional, that leakage and swelling to the patient's arm had occurred as well as discomfort at the insertion site.It was reported that there may be damage to the picc.

• Brand Name: 5 FR DL POWERPICC SOLO CATHETER, BASIC
• 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: 6139747
• Report Number: 3006260740-2016-00640
• Device Sequence Number: 13547210
• Product Code: LJS
• UDI-Device Identifier: 00801741028090
• UDI-Public: (01)00801741028090(17)170628(10)REZL2475
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/09/2016

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: 06/28/2017
• Device Catalogue Number: 3295118
• Device Lot Number: REZL2475
• 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: 12/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1