MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CLEARVUE ISP IMPLANTABLE PORT WITH SMOOTH SEPTUM AND ATTACHABLE 8F; SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER

Model Number	N/A
Health Effect - Clinical Code	Unspecified Infection (1930)
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.A lot history review (lhr) of rebn0211 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Facility reported to the sales rep that the infected port was removed.No other information was reported, but has been requested.
Additional Manufacturer Narrative
The initial complaint appeared to be a reportable occurrence.Upon receiving additional information about the event, it was determined that a reportable event had not occurred.This event involved an implanted port and is covered by exemption e1997041; therefore, it will be reported as part of the quarterly summary report.
Event or Problem Description
Facility reported to the sales rep that the infected port was removed.No other information was reported, but has been requested.

• Brand Name: POWERPORT CLEARVUE ISP IMPLANTABLE PORT WITH SMOOTH SEPTUM AND ATTACHABLE 8F
• Common Device Name: SUBCUTANEOUS, IMPLANTED, INTRAVASCULAR INFUSION PORT AND CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6623953
• Report Number: 3006260740-2017-00743
• Device Sequence Number: 855247
• Product Code: LJT
• UDI-Device Identifier: 00801741041952
• UDI-Public: (01)00801741041952(17)191231(10)REBN0211
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2017

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: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 5668362
• Device Lot Number: REBN2011
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 06/08/2017
• Supplement Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1