MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CLEARVUE ISP IMPLANTABLE PORT WITH SMOOTH SEPTUM AND ATTACHABLE 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	5666362
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.Photographs have been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that the patient's id card does not state anything concerning the use of heparin flush and also states the incorrect flush frequency.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot number was provided and the lot device history records have been reviewed.The lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint that has been reported for this corporate lot number to date.Investigation summary: although the sample was not returned for evaluation, two electronic photos were provided for review.The investigation confirms that the patient id card doesn't specify heparin dosage.It also confirms that the dose frequency is incorrect as it mentions 90 days as current nursing guide literature specifies 4 weeks (28days).Confirmed, design related.This has been identified as a documentation content issue.Although no specific lot number apples to this complaint, actions have been created prior to address inappropriate instructions in the powerport clearvue id card that existed at the time of this complaint.Labeling review: the id card states to flush with saline every 90 days; however it should be flushed with heparin every 28 days.
Event or Problem Description
It was reported that the patient's id card does not state anything concerning the use of heparin flush and also states the incorrect flush frequency.There was no reported patient injury.

• Brand Name: POWERPORT CLEARVUE ISP IMPLANTABLE PORT WITH SMOOTH SEPTUM AND ATTACHABLE 6F
• 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: 7980026
• Report Number: 3006260740-2018-02932
• Device Sequence Number: 1381635
• Product Code: LJT
• UDI-Device Identifier: 00801741110733
• UDI-Public: (01)00801741110733
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K063377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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 Expiration Date: 03/31/2019
• Device Model Number: 5666362
• Device Catalogue Number: 5666362
• Device Lot Number: REBX1517
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 04/13/2019
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1