MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP MRI 6F CHRONW/OS; IMPLANTABLE PORT

Catalog Number 8806061

Device Problems Burst Container or Vessel (1074); Material Discolored (1170); Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, the devices was not returned to bd.An x-ray image and photo was provided and is currently underway review.The company is still investigating the issue at this time.The device was labeled for single use.The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 8806061.Implantable port allegedly experienced burst container or vessel.This report was received from a single source.This malfunction did involve patient with no reported patient injury.The patient is 65 years of age, the gender is male, and the weight is 60 kgs.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 8806061.Implantable port allegedly experienced burst container or vessel.This report was received from a single source.This malfunction did involve patient with no reported patient injury.The patient was 65 years old, the gender was male and the weight was 60 kg.

Manufacturer Narrative

H10: the lot number for the device was not provided and a lot history review could not be performed.For the one reported malfunction, the device was not returned for evaluation.An x-ray image and electronic photo was provided and reviewed.Based on the photo review, a partial fracture in the catheter and catheter discoloration can be confirmed.The definitive root cause could not be determined based upon available information.The device was labelled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: POWERPORT ISP MRI 6F CHRONW/OS
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9602605
• MDR Text Key: 192047323
• Report Number: 3006260740-2020-00228
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098963
• UDI-Public: (01)00801741098963
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8806061
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/29/2020
• Patient Sequence Number: 1