MAUDE Adverse Event Report: BARD ACCESS SYSTEMS M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F; IMPLANTED PORT

Model Number 0602833

Device Problems Material Separation (1562); Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned to the manufacturer for evaluation.Therefore, the investigation for the reported malfunction is confirmed for material separation, however,the investigation is inconclusive for syringe delivered as defective issue.Based on the available information, 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 indicates that model 0602833 implanted port allegedly experienced material separation and defective component.The information was received from a single source.This malfunction did not involve a patient as there was no patient contact.The patient age, weight, and gender were not provided.

• Brand Name: M.R.I. IMPLANTABLE PORT, GROSHONG SINGLE-LUMEN, KIT, 8F
• Type of Device: IMPLANTED 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: 11211200
• MDR Text Key: 228170560
• Report Number: 3006260740-2021-80004
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741025723
• UDI-Public: (01)00801741025723
• 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

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0602833
• Device Catalogue Number: 0602833
• Device Lot Number: REDQ1154
• Date Manufacturer Received: 12/31/2020
• Type of Device Usage: N
• Patient Sequence Number: 1