MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT ISP MRI 6CF INT W SP, ATT, SL; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number 8806060

Device Problem Fluid/Blood Leak (1250)

Patient Problems Edema (1820); Extravasation (1842); Swelling (2091)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Medical device expiry date: 03/2021.

Event Description

It was reported that approximately four months post port placement, through chest x-ray examination revealed leak and extravasation from the port.It was further reported that the patient experienced recurrent pain and swelling in the area of the left pectoral port and neck - jugular after chemotherapy.Reportedly the port was removed.The patient status is unknown.

Manufacturer Narrative

H10: manufacturing review:a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary:one powerport mri isp attached to catheter was returned for evaluation.Visual, microscopic and functional evaluation was performed on the device.The investigation is unconfirmed for the reported fluid leak as both the port and the catheter segment was patent to infusion and aspiration without any issue.A definitive root cause could not be determined based upon available information.Labeling review:a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4(expiry date: 03/2021),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 approximately four months post port placement, through chest x-ray examination revealed leak and extravasation from the port.It was further reported that the patient experienced recurrent pain and swelling in the area of ¿¿the left pectoral port and neck - jugular after chemotherapy.Reportedly the port was removed.The patient status is unknown.

• Brand Name: POWERPORT ISP MRI 6CF INT W SP, ATT, SL
• 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: 10389841
• MDR Text Key: 202349378
• Report Number: 3006260740-2020-02877
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098956
• UDI-Public: (01)00801741098956
• Combination Product (y/n): N
• PMA/PMN Number: K072549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8806060
• Device Lot Number: REDY0882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR