MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. QUICKLINK LOADER

Catalog Number 70310QCA1

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided, therefore a lot history review was not performed.The sample was returned for evaluation and the investigation is confirmed for cracked plastic piece and packaging problem.The definitive root cause could not be determined based upon available information.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 70310qca1 quicklink loader allegedly experienced packaging issue.This information was received from one source.This malfunction does not involved patient.The patient's age, weight and gender were 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: the serial number was provided, therefore a review of the device history record was performed.The sample was returned for evaluation and the investigation is confirmed for cracked plastic piece and packaging problem.The definitive root cause could not be determined based upon available information.The device was 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 70310qca1 quicklink loader allegedly experienced packaging issue.This information was received from one source.This malfunction does not involved patient.The patient's age, weight and gender were not provided.

• Brand Name: QUICKLINK LOADER
• Type of Device: QUICKLINK LOADER
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC.; 295 east lies road; carol stream IL 60188
• MDR Report Key: 10741942
• MDR Text Key: 213255313
• Report Number: 2020394-2020-06139
• 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: 10/27/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 70310QCA1
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/31/2021
• Patient Sequence Number: 1