MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F

Model Number 1616000

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the reported malfunction was not provided, therefore, a lot history review could not be performed.The device was not returned to the manufacturer for evaluation; however a photo was provided for review.Therefore, the investigation of the reported event is currently underway.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates the model 1616000 implantable port allegedly experienced incorrect catalog number on the barcode of the device.The report was received from a single source.This malfunction involved patient with no known impact to the patient.The patient's age, gender and weight was not provided.

Manufacturer Narrative

H10: the lot number for the device was provided and a lot history review was performed.The device was not returned to the manufacturer for evaluation; however, two electronic photos were provided for review.The investigation is inconclusive for incorrect barcode.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.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

This report summarizes one malfunction.A review of the reported information indicates the model 1616000 implantable port allegedly experienced incorrect catalog number on the barcode of the device.The report was received from a single source.This malfunction involved patient with no known impact to the patient.The patient's age, gender and weight was not provided.

• Brand Name: POWERPORT CLEARVUE SLIM IMPLANTABLE PORT, CHRONOFLEX SINGLE-LUMEN, KIT, 6F
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10738148
• MDR Text Key: 213199608
• Report Number: 3006260740-2020-03492
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741026447
• UDI-Public: (01)00801741026447
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1616000
• Device Catalogue Number: 1616000
• Device Lot Number: REES1577
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1