MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. QUICKLINK STANDARD LINK #20; QUICK LINK CARTRIDGES

Catalog Number 70301QC20

Device Problem Missing Information (4053)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a lot history review was not performed.The sample was not returned to the manufacturer for inspection/evaluation.The ifu labeling was reviewed and was found to be adequate and available in multiple languages.The definitive root cause for the reported event could not be determined based on the provided information.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 70301qc20 quick link cartridges's instruction for use (ifu) allegedly experienced difficult to understand.This information was received from one source.The one reported malfunction did not involve a patient.The age, sex and weight of the patient was not provided.

Manufacturer Narrative

H10: the initial report was submitted with an incorrect fda rn number.The correct fda rn number is (b)(4).H10: as the lot number for the device was not provided, a lot history review was not performed.The sample was not returned to the manufacturer for inspection/evaluation.The ifu labeling was reviewed and was found to be adequate and available in multiple languages.The definitive root cause for the reported event could not be determined based on the provided information.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 indicated that model 70301qc20 quick link cartridges's instruction for use (ifu) allegedly experienced difficult to understand.This information was received from one source.The one reported malfunction did not involve a patient.The age, sex and weight of the patient was not provided.

• Brand Name: QUICKLINK STANDARD LINK #20
• Type of Device: QUICK LINK CARTRIDGES
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC.; 295 east lies road; carol stream IL 60188
• MDR Report Key: 10756880
• MDR Text Key: 213878404
• Report Number: 2020394-2020-06276
• Device Sequence Number: 1
• Product Code: KXK
• 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: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 70301QC20
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/31/2021
• Patient Sequence Number: 1