MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number 1618000

Device Problems Reflux within Device (1522); Material Too Rigid or Stiff (1544); Blocked Connection (2888)

Patient Problems Chest Pain (1776); Inflammation (1932); Pain (1994)

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: 08/2021).

Event Description

It was reported that during a port placement, patient bloodwork was comes back with generalized inflammation and they have been giving her prednisone to prevent.The patient status was 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: the device was not returned.The investigation is inconclusive for the reported bleed back and unable to access issue, as the device was not returned for evaluation.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: 08/2021),g4.H11: h6(method).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 some time post port placement, the hcp allegedly had difficulty in accessing the port due to the hardness in port septum.Reportedly, the patient bloodwork comes back with generalized inflammation and prescribed prednisone to prevent.The patient experienced pain in chest and under arm on that side.The patient status was unknown.

• Brand Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 8F
• 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: 10584900
• MDR Text Key: 208492800
• Report Number: 3006260740-2020-03377
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026485
• UDI-Public: (01)00801741026485
• Combination Product (y/n): N
• PMA/PMN Number: K122899
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1618000
• Device Catalogue Number: 1618000
• Device Lot Number: REEQ1609
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention