MAUDE Adverse Event Report: BARD ACCESS SYSTEMS XPORT ISP MRI 6FR CFLEX W/ INTER KIT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	0607530
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided, therefore a lot history review was performed.The device was not returned for evaluation, however a photo was provided for review.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0607530 port and catheter allegedly experienced a fluid leak.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.
Additional Manufacturer Narrative
The lot number was provided and a lot history review was performed.The device and a photo of the sample were provided for review.The evaluation of the sample and review of the photo were inconclusive for fluid leak.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0607530 port and catheter allegedly experienced a fluid leak.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.

• Brand Name: XPORT ISP MRI 6FR CFLEX W/ INTER KIT
• 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: 9209193
• Report Number: 3006260740-2019-03150
• Device Sequence Number: 3107901
• Product Code: LJT
• UDI-Device Identifier: 00801741026171
• UDI-Public: (01)00801741026171
• 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): 01/06/2020

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: 0607530
• Device Catalogue Number: 0607530
• Device Lot Number: RECZ3439
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/18/2019
• Supplement Report FDA Received Date: 01/06/2020
• Patient Sequence Number: 1