MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 0.33MCI 1251 BRACHYSOURCE; BRACHYTHERAPY EQUIPMENT & ACCESSORIES

Catalog Number STM1251033MCI

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 02/17/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturing review: a device history record review was performed for the affected lot number of the seeds and the lot number of the seed cartridge.No issues were noted.Investigation summary: the sample was not returned for evaluation.Therefore, the investigation is inconclusive for the reported issue.The definitive root cause could not be determined based upon available information.Labeling review: labeling was reviewed and found to be adequate.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." device not returned.

Event Description

It was reported that during a brachytherapy procedure, the linked seed which was connected two seeds and a connector was allegedly stuck within the needle adapter, and could not be inserted into the relay applicator.The seeds and a connector were collected in the next day.There was no reported patient injury.

• Brand Name: 0.33MCI 1251 BRACHYSOURCE
• Type of Device: BRACHYTHERAPY EQUIPMENT & ACCESSORIES
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• Manufacturer (Section G): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13786366
• MDR Text Key: 287336977
• Report Number: 1018233-2022-01332
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K093663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: STM1251033MCI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Male