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

Catalog Number 70301QC20

Device Problem Positioning Failure (1158)

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

Event Type  malfunction  

Manufacturer Narrative

The lot no for the device was provided, therefore a lot history review was performed.The device was returned for evaluation.The investigation is unconfirmed for reported positioning failure.Based upon the available information, the definitive root cause for this event is unknown.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 seed linker allegedly experienced positioning failure.This information was received from one source.This malfunction did not involve a patient as there was no patient contact.Age and weight of the male patient were not provided.

Manufacturer Narrative

H10: the initial report was submitted with an incorrect fda rn number.The correct fda rn number is 1018233.H10: the lot no for the device was provided, therefore a lot history review was performed.The device was returned for evaluation.The investigation is unconfirmed for reported positioning failure.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H10: g3.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 seed linker allegedly experienced positioning failure.This information was received from one source.This malfunction did not involve a patient as there was no patient contact.Age and weight of the male patient were not provided.

• Brand Name: QUICKLINK STANDARD LINK #20
• Type of Device: QUICK LINK SEED LINKER
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC.; 295 east lies road; carol stream IL 60188
• MDR Report Key: 10752531
• MDR Text Key: 213648757
• Report Number: 2020394-2020-06230
• 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: 10/28/2020
• 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: BBET0037
• Date Manufacturer Received: 03/31/2021
• Patient Sequence Number: 1