MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 I125 SEEDS IN QUICKLINK, STERILE, 11.0 MBQ; BRACHYTHERAPY SEEDS

Catalog Number 1251QCS1

Device Problem Positioning Failure (1158)

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

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.

Event Description

It was reported that during a brachytherapy procedure, the seed allegedly could not be discharged from the loader.In addition, the seed migrated into the loader.There was no reported patient injury.

Event Description

It was reported that during a brachytherapy procedure, the seed allegedly could not be discharged from the loader.In addition, the seed migrated into the loader.There was no reported patient injury.

Manufacturer Narrative

H10: upon additional information, five samples were received, however, the failure event was occurred only one sample and also it cannot be determined which sample malfunctioned among the returned five devices, therefore, all the five devices evaluation details will be captured in the mdr.H10: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: five (5) empty seed cartridges were returned for evaluation and labeled as biohazardous.Upon initial inspection, the seed cartridges gates closed properly.No spring protrusion was noticed on the backside of the cartridges.Plunger travel appeared fine.Twenty seeds were loaded into the cartridges and inserted into a quicklink loader.All 20 seeds dispensed as expected on all five (5) cartridges with no issues noted.The complaint was found unconfirmed for reported issue.The definitive root cause could not be determined based upon available information.Labeling review: the information for use was reviewed.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.".

• Brand Name: I125 SEEDS IN QUICKLINK, STERILE, 11.0 MBQ
• Type of Device: BRACHYTHERAPY SEEDS
• 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: 12809609
• MDR Text Key: 285162338
• Report Number: 1018233-2021-07233
• 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,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1251QCS1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2021
• 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
• Patient Sex: Male