MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT SLIM IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F

Model Number 1718500

Device Problem Inaccurate Information (4051)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a lot history review cannot be performed.The sample was not returned to the manufacturer for inspection/evaluation; therefore, the investigation of the reported event is inconclusive for inaccurate information.A definitive root cause for the reported event 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 1718500 implantable port allegedly had inaccurate information.The information was received from a single source.This malfunction involved one patient with no patient consequences.A female patient weight and age was not provided.

• Brand Name: POWERPORT SLIM IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, 8F
• 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: 10742571
• MDR Text Key: 213299041
• Report Number: 3006260740-2020-03496
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026812
• UDI-Public: (01)00801741026812
• 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: 10/27/2020

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
• Device Operator: No Information
• Device Model Number: 1718500
• Device Catalogue Number: 1718500
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/27/2020
• Type of Device Usage: N
• Patient Sequence Number: 1