MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F; IMPLANTED PORT

Model Number 1708070

Device Problems Difficult to Insert (1316); Suction Problem (2170); Failure to Infuse (2340)

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 not returned for evaluation.Therefore, the investigation is inconclusive for the reported difficult to insert, unable to infuse and aspirate 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 indicated that model 1708070 implanted port allegedly experienced difficult to insert, unable to infuse and aspirate issue.This information was received from one source.This malfunction did not involve a patient as there was no patient contact.Age, weight, and gender were not provided.

• Brand Name: POWERPORT IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 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: 11211388
• MDR Text Key: 228170683
• Report Number: 3006260740-2021-80009
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026652
• UDI-Public: (01)00801741026652
• 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: 1708070
• Device Catalogue Number: 1708070
• Device Lot Number: REEP4309
• Initial Date Manufacturer Received: 12/31/2020
• Initial Date FDA Received: 01/21/2021
• Type of Device Usage: N
• Patient Sequence Number: 1