MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F

Catalog Number 1806050J

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Suction Problem (2170)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us, but is similar to the powerport isp m.R.I.Implantable port, chronoflex single-lumen, kit, 6f products that are cleared in the us.The pro code for the powerport isp m.R.I.Implantable port, chronoflex single-lumen, kit, 6f products is identified in common device name.As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation.The investigation is confirmed for fracture, fluid leak and suction problem.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 indicated that model 1806050j implantable port allegedly experienced fluid leak, fracture and suction problem.This information was received from one source.This malfunction did not involve a patient as there was no patient contact.The patient age, sex and weight were not provided.

• Brand Name: POWERPORT ISP M.R.I. IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F
• 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: 11216398
• MDR Text Key: 229098852
• Report Number: 3006260740-2021-80012
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741163746
• UDI-Public: (01)00801741163746
• 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: 01/22/2021

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 Catalogue Number: 1806050J
• Device Lot Number: REDV1543
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/22/2021
• Type of Device Usage: N
• Patient Sequence Number: 1