MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT DUO MRI 9.5 FR. D/L CHRONOFLEX, MICRO W/ SP; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1829570
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 1829570 port & catheter, implanted, subcutaneous, intravascular the patient alleged pressure towards the end of the ct scan.This report was received from a single source.Of the one event, did involve patient with no reported patient injury.The patient is (b)(6) years of age, the gender is male, and the weight is (b)(6).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 1829570.Port & catheter, implanted, subcutaneous, intravascular allegedly experienced device dislodged or dislocated.This report was received from a single source.This event did involve patient with no patient consequences.The patient is 68 years of age, the gender is male, and the weight is 180 lbs.
Additional Manufacturer Narrative
The device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged dislodged septum as no objective evidence has been provided to confirm any alleged deficiency with the septum.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.The device was labeled for single use.

• Brand Name: POWERPORT DUO MRI 9.5 FR. D/L CHRONOFLEX, MICRO W/ SP
• 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: 8529015
• Report Number: 3006260740-2019-00992
• Device Sequence Number: 19532582
• Product Code: LJT
• UDI-Device Identifier: 00801741027192
• UDI-Public: (01)00801741027192
• 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: 1829570
• Device Catalogue Number: 1829570
• Device Lot Number: REXJ0088
• 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: 07/23/2019
• Patient Sequence Number: 1