MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD POWERPORT VUE M.R.I 6 F ATTACHABLE CHRONOFLEX; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1806062
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A photo of the device was provided and the return of the device is pending.As the lot number for the device was provided, a review of the device history records is currently being performed.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during preparation for port placement upon opening the port kit, the port septum was allegedly noted to have a slice in it.Another port kit was opened and placed.There was no reported patient contact.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: although the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for damaged/defective septum, as the photo shows one clean slash through the middle of the septum.The definitive root cause could not be determined based upon available information.It is unknown if clinical or manufacturing procedures contributed to the reported event.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.(expiry date: 4/2019).
Event or Problem Description
It was reported that during preparation for port placement upon opening the port kit, the port septum was allegedly noted to have a slice in it.Another port kit was opened and placed.There was no reported patient contact.

• Brand Name: BARD POWERPORT VUE M.R.I 6 F ATTACHABLE CHRONOFLEX
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8266047
• Report Number: 3006260740-2019-00056
• Device Sequence Number: 16716234
• Product Code: LJT
• UDI-Device Identifier: 00801741026966
• UDI-Public: (01)00801741026966
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2019

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: 1806062
• Device Catalogue Number: 1806062
• Device Lot Number: REBY0158
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/27/2018
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 01/22/2019
• Supplement Report FDA Received Date: 04/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1