MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP MRI, 6.0 FR, INT., CHRONOFLEX, OPEN; IMPLANTABLE PORT

Model Number 1806061

Device Problems No Display/Image (1183); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction is unknown, therefore a lot history review will not be performed.The device was not returned for evaluation, however, a radiographic image was provided for review.The investigation is confirmed for the reported failure to display issue as well as material deformation.The definitive root cause could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 1806061 implantable port allegedly experienced failure to display and material deformation.The information was received from one source.The malfunction involved a patient with no patient injury.The male patient is (b)(6) years old and weighs (b)(6).

• Brand Name: POWERPORT ISP MRI, 6.0 FR, INT., CHRONOFLEX, OPEN
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9599199
• MDR Text Key: 191153909
• Report Number: 3006260740-2020-00176
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026959
• UDI-Public: (01)00801741026959
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1806061
• Device Catalogue Number: 1806061
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/16/2020
• Type of Device Usage: N
• Patient Sequence Number: 1