MAUDE Adverse Event Report: BARD ACCESS SYSTEMS MRI IMPLANTABLE PORT W/ATTACHABLE 8 FR GROSHONG S/L VENOUS CATHETER

Catalog Number 0602830T

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

A lot number was not provided so a lot history review was not performed.The device for the reported malfunction was not returned to bd for evaluation; however a medical image was provided for review.The investigation is still underway.The catalog number identified has not been cleared in the us, but is similar to the sm att plas+8fr grosh+ki products that are cleared in the us.The pro code for the sm att plas+8fr grosh+ki products is identified.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 0602830t implantable port allegedly experienced a burst.This information was received from one source.This malfunction did involve a patient with no reported patient injury.The patient was a (b)(6) year old female that weighed (b)(6).

Manufacturer Narrative

H10: the lot number was not provided, therefore a lot history review was not performed.The sample was not returned and the investigation is confirmed for a fracture in the catheter by the image review.The definitive root cause could not be determined based upon available information.The device was labeled 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.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 0602830t implantable port allegedly experienced a burst.This information was received from one source.This malfunction did involve a patient with no reported patient injury.The patient was a 66 year old female that weighed 55 kgs.

• Brand Name: MRI IMPLANTABLE PORT W/ATTACHABLE 8 FR GROSHONG S/L VENOUS CATHETER
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9598345
• MDR Text Key: 191156048
• Report Number: 3006260740-2020-00164
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741140303
• UDI-Public: (01)00801741140303
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 0602830T
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 06/29/2020
• Supplement Dates FDA Received: 06/30/2020
• Patient Sequence Number: 1