MAUDE Adverse Event Report: BARD ACCESS SYSTEMS M.R.I. HARD BASE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F

Model Number 0605450

Device Problems Fracture (1260); Deformation Due to Compressive Stress (2889)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation and photos were provided for review.Therefore, the investigation is confirmed for the reported deformation issue and identified fracture issue.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 0605450 implantable port allegedly experienced fracture and deformation due to compressive stress.The information was received from a single source.This malfunction did not involve a patient as there was no patient contact.Patients' age, weight and gender were not provided.

• Brand Name: M.R.I. HARD BASE IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 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: 11211147
• MDR Text Key: 228170161
• Report Number: 3006260740-2021-80003
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025945
• UDI-Public: (01)00801741025945
• 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: 01/21/2021

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: 0605450
• Device Catalogue Number: 0605450
• Device Lot Number: RECZ3433
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/21/2021
• Type of Device Usage: N
• Patient Sequence Number: 1