MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOME SUBQ PORT,HICKMAN W; IMPLANTABLE PORT

Model Number 0602870

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided and a lot history review was performed.The device was not returned for evaluation, therefore the investigation is inconclusive for the reported failure.The definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 0602870 implantable port allegedly frayed material.This information was received from one source.One patient was involved and there was no reported patient injury.The patient is female and age and weight were not provided.

• Brand Name: DOME SUBQ PORT,HICKMAN W
• 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: 9205777
• MDR Text Key: 164417889
• Report Number: 3006260740-2019-03120
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025778
• UDI-Public: (01)00801741025778
• 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: 10/17/2019

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
• Device Operator: No Information
• Device Model Number: 0602870
• Device Catalogue Number: 0602870
• Device Lot Number: RECW1211
• Initial Date Manufacturer Received: 09/30/2019
• Initial Date FDA Received: 10/17/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1