MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT TITANIUM ISP S/L, ATTACHABLE; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1706060
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Of the two malfunctions, one lot number was provided, and a lot history review will be performed.For the two reported information, the samples were not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported malfunctions is inconclusive.Based upon the available information, the definitive root cause for the malfunctions is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.The devices are labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 1706060.Port & catheter allegedly experienced a break.This report was received from various sources.These malfunctions did involve patient with no reported patient injury.Both patients are female, one patient is (b)(6) years of age and is (b)(6) kgs, the other patient's age and weight were not provided.

• Brand Name: POWERPORT TITANIUM ISP S/L, ATTACHABLE
• 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: 8808880
• Report Number: 3006260740-2019-02069
• Device Sequence Number: 343278
• Product Code: LJT
• UDI-Device Identifier: 00801741026546
• UDI-Public: (01)00801741026546
• 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
• Report Date (Section B): 07/19/2019

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: No Information
• Device Model Number: 1706060
• Device Catalogue Number: 1706060
• Device Lot Number: REAS2177
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/19/2019
• Patient Sequence Number: 1