MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CV SLIM SPNB 6 FR CHRONOFLEX SLTH; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	5676300
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the one reported event, the device was returned to bd and evaluated.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 5676300 port & catheter, implanted, subcutaneous, intravascular the incorrect size was allegedly identified.This report was received from a single source.Of the one event, did not involve patient.The patients age, weight and gender were not provided.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model 5676300 port & catheter, implanted, subcutaneous, intravascular the incorrect size was allegedly identified.This report was received from a single source.Of the one event, did not involve patient.The patients age, weight and gender were not provided.
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device has been returned for evaluation and a photo of the malfunction was reviewed; the investigation is inconclusive for incorrect component, as there was not enough evidence provided to ensure that these cathlocks were indeed included in a powerport clearvue slim implantable port w 6 fr s/l white polyurethane kit.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

• Brand Name: POWERPORT CV SLIM SPNB 6 FR CHRONOFLEX SLTH
• 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: 8533002
• Report Number: 3006260740-2019-01082
• Device Sequence Number: 13856036
• Product Code: LJT
• UDI-Device Identifier: 00801741110771
• UDI-Public: (01)00801741110771
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2019

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: No Information
• Device Model Number: 5676300
• Device Catalogue Number: 5676300
• Device Lot Number: RECX3530
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1