MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. BRACHYTHERAPY; BRACHY SEEDS

Catalog Number Z70/94

Device Problem Positioning Failure (1158)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided for the malfunction and a lot history review will not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.A definitive root cause could not be determined.The device is labeled for single use.

Event Description

This report summarizes three malfunctions.A review of the reported information indicated that model z70/94 brachy seeds allegedly experienced jammed seeds.This information was received from one source.This malfunction involved one patient with no consequences.The male patient's age and weight is unknown.

Manufacturer Narrative

Changed to: h10: the initial report was submitted with an incorrect fda rn number.The correct fda rn number is 1018233.H10: the lot number was not provided for the malfunction and a lot history review will not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.A definitive root cause could not be determined.The device is labeled for single use.H10: g3.H11: d3.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 three malfunctions.A review of the reported information indicated that model z70/94 brachy seeds allegedly experienced jammed seeds.This information was received from one source.This malfunction involved one patient with no consequences.The male patient's age and weight is unknown.

• Brand Name: BRACHYTHERAPY
• Type of Device: BRACHY SEEDS
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC.; 295 east lies road; carol stream IL 60188
• MDR Report Key: 10314932
• MDR Text Key: 200206262
• Report Number: 2020394-2020-05007
• 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: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: Z70/94
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/31/2021
• Patient Sequence Number: 1