MAUDE Adverse Event Report: BARD ACCESS SYSTEMS CUSTOM PP TI ISP NB 6F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	CP00001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model cp00001 custom pp ti isp nb 6f experienced a fluid leak.For this event, the device was used on the patient with no reported injury.The patient was a (b)(6)-year-old male weighing (b)(6) kgs.The cp00001 custom pp ti isp nb 6f was returned to the manufacturer.The device is pending investigation.
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; the investigation is confirmed for a fluid leak.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction event.A review of the event indicated that model cp00001 port & catheter, implanted, subcutaneous, intravascular allegedly experienced a fluid leak.This information was received from a single source.For this event, the device was used on the patient with no reported injury.The patient was a 15-year-old male weighing 49 kgs.

• Brand Name: CUSTOM PP TI ISP NB 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: 8529413
• Report Number: 3006260740-2019-00996
• Device Sequence Number: 1928788
• Product Code: LJT
• UDI-Device Identifier: 00801741111471
• UDI-Public: (01)00801741111471
• 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): 07/24/2019

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: CP00001
• Device Catalogue Number: CP00001
• Device Lot Number: REBN2109
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1