MAUDE Adverse Event Report: BARD ACCESS SYSTEMS APHERESIS PORT ACCESS SYSTEM; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number UNK APHERESIS PORT ACCESS SYS

Device Problems Restricted Flow rate (1248); Deformation Due to Compressive Stress (2889)

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 cannot be performed.The device was not returned for evaluation.Therefore, the investigation is inconclusive for the reported malfunctions.A definitive root cause for the reported event could not be determined.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model unknown port & catheter, implanted, subcutaneous, intravascular allegedly experienced restricted flow rate and deformation due to compressive stress.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, sex and weight of the patient were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model unk apheresis port access sys port & catheter, implanted, subcutaneous, intravascular allegedly experienced restricted flow rate and deformation due to compressive stress.This information was received from one source.The malfunction involved a patient with no known impact to the patient.The age, sex and weight of the patient were not provided.

Manufacturer Narrative

H10: the lot number for the reported malfunction was not provided, therefore a lot history review cannot be performed.The device was not returned for evaluation.Therefore, the investigation is inconclusive for the reported restricted flow rate and deformation due to compressive stress.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.

• Brand Name: APHERESIS PORT ACCESS SYSTEM
• 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: 10737695
• MDR Text Key: 213121564
• Report Number: 3006260740-2020-03473
• Device Sequence Number: 1
• Product Code: LJT
• 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: 01/08/2021

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 Catalogue Number: UNK APHERESIS PORT ACCESS SYS
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 12/31/2020
• Patient Sequence Number: 1