MAUDE Adverse Event Report: BARD ACCESS SYSTEMS VACCESS CT W/8FR CF CATHETER INT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 7480000

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

Patient Problems Death (1802); Sepsis (2067)

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.(expiration date: 04/2021).

Event Description

It was reported that after a vaccess ct port placement, the port access needle was left in the patient with dressing for approximately sixteen days.It was further reported that the patient expired; however, patient's cause of death surrounding or related to the port device was not provided.It was further reported that the patient developed sepsis which was treated in the hospital.

Manufacturer Narrative

H10: 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.H10: d4 (expiration date: 04/2021), g4.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

It was reported that after a v-access ct port placement, the port access needle was left in the patient with dressing for approximately sixteen days.It was further reported that the patient expired; however, patient's cause of death surrounding or related to the port device was not provided.It was further reported that the patient developed sepsis which was treated in the hospital.

• Brand Name: VACCESS CT W/8FR CF CATHETER INT
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10092124
• MDR Text Key: 192180939
• Report Number: 3006260740-2020-01849
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741027475
• UDI-Public: (01)00801741027475
• Combination Product (y/n): N
• PMA/PMN Number: K063377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 7480000
• Device Catalogue Number: 7480000
• Device Lot Number: REDV3032
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/04/2020
• Initial Date FDA Received: 05/27/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 69 YR