MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT M.R.I IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F

Model Number 1808000

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problem Nervous System Injury (2689)

Event Type  Injury  

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.(expiry date: 04/2021).

Event Description

It was reported that the post port implantation, the patient allegedly experienced hardened vein in the right side of the neck.The patient status is stable.

Event Description

It was reported that the post port implantation, the patient allegedly experienced hardened vein in the right side of the neck.The patient status is stable.

Manufacturer Narrative

H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: a sample evaluation could not be performed, as the device was not returned.Therefore, the report of hardened vein cannot be confirmed.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.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 M.R.I IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, 8F
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10262761
• MDR Text Key: 198495093
• Report Number: 3006260740-2020-02407
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741000430
• UDI-Public: (01)00801741000430
• 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: 11/03/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 1808000
• Device Catalogue Number: 1808000
• Device Lot Number: REDW1469
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/17/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other