MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 I125 SEEDS IN QUICKLINK, STERILE, 13.1 MBQ; BRACHYTHERAPY LINKS & CARTRIDGES

Catalog Number 1251QCS2

Device Problem Positioning Failure (1158)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/31/2021

Event Type  malfunction  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the brachysource i-125 seeds in quicklink cartridge single, sterile products that are cleared in the us.The pro code and 510 k number for the brachysource i-125 seeds in quicklink cartridge single, sterile products are identified.Manufacturing review: a device history record review was performed for the affected lot numbers of the seeds and the lot number of the cartridge.These lots met all release criteria.However, this product code is not designated with a lot number, this information is not applicable for the history review.Investigation summary: one empty seed cartridge was returned from the customer for evaluation and was labeled as biohazardous.Upon initial inspection, the seed cartridge gate closure on the catridges worked as expected.No spring protrusions were noticed on the backside of the cartridge and the plunger traveled appropriately.Twenty seeds were loaded into the cartridge and inserted into a quicklink loader.All 20 seeds from the cartridge dispensed as expected.Upon completion of dispensing, the cartridge was removed from the loader and examined.No issues noted.Therefore, the investigation is unconfirmed for the reported issue.Based upon the available information a definitive root cause could not be determined.Labeling review: the information for use was reviewed for quicklink delivery system.There is a caution statement, which states "in the event the quicklink¿ loader or cartridges become inoperable due to damage or malfunction, any or all components may be removed from the cartridges and implanted manually.".

Event Description

It was reported that during a brachytherapy procedure, the seeds allegedly could not be discharged from the loader.There was no reported patient injury.

• Brand Name: I125 SEEDS IN QUICKLINK, STERILE, 13.1 MBQ
• Type of Device: BRACHYTHERAPY LINKS & CARTRIDGES
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• MDR Report Key: 12538458
• MDR Text Key: 273527829
• Report Number: 1018233-2021-06017
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• PMA/PMN Number: K093663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1251QCS2
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Date Manufacturer Received: 09/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1