MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP TI W ATTACH OPEN ENDED 8 FR CHRONOFLEX; IMPLANTABLE PORT

Model Number 4708060

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Device expiry date (11/2019).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

It was reported approximately two years post port device implant, the patient allegedly expired; however, patient's cause of death surrounding or related to the device was not provided.

Manufacturer Narrative

After further review of this event, it has been determined that this event is not reportable.There was no reported device deficiency.A death certificate was provided which stated the cause of death was metastatic colon cancer.Therefore, it has been determined that this event is no longer reportable.Manufacturing review: the lot number was provided and a lot history review was performed.Investigation summary: a sample evaluation could not be performed as the device was not returned.No allegation of device malfunction was made.A death certificate provided stated that the cause of death was metastatic colon cancer and that there was no autopsy performed.No malfunction was discovered through evaluation as no sample was returned.Therefore, no root cause is applicable.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.Expiry date (11/2019).

Event Description

It was reported approximately two years post port device implant, the patient allegedly expired; however, patient's cause of death surrounding or related to the device was not provided.

• Brand Name: POWERPORT ISP TI W ATTACH OPEN ENDED 8 FR CHRONOFLEX
• 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: 10103138
• MDR Text Key: 193003837
• Report Number: 3006260740-2020-01919
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027284
• UDI-Public: (01)00801741027284
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4708060
• Device Catalogue Number: 4708060
• Device Lot Number: RECN0108
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death