MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 IODINE QL STERILE 13.1MB; BRACHYTHERAPY LINKS AND CARTRIDGES

Catalog Number 1251QCS2

Device Problems Failure to Advance (2524); Detachment of Device or Device Component (2907)

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

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was not provided, a review of the device history record could not be performed.The device has not been returned to the manufacturer for evaluation.However, a photo is provided for review.The investigation of the reported event is currently underway.The catalog number identified in section 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.

Event Description

It was reported that the l spring attached to the seed cartridge allegedly detached from the groove and could not be loaded into the carriage.It was further reported that the seeds were taken out one by one to deal with it.There was no reported patient injury.

Event Description

It was reported that the l spring attached to the seed cartridge allegedly detached from the groove and could not be loaded into the carriage.It was further reported that the seeds were taken out one by one to deal with it.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a device history review could not be performed as the lot number is unknown.Investigation summary: the sample was returned for evaluation.One empty seed cartridge was returned from the customer.Upon initial inspection, it was noticed that the gate closed properly.No spring protrusion was noticed on the backside of the cartridges, and both wireform springs were present and seated with their respective notches.Plunger travel appeared fine.Twenty seeds were loaded into the cartridge and inserted into a quicklink loader.All 20 seeds were dispensed as expected with no issues noted.When dispensing was complete, the cartridge was examined under magnification.No flash was present.Wireform springs were seated properly.Based on the photo provided, this complaint is confirmed for detached spring; however, the reported condition was not duplicated during evaluation of the actual sample.A definite root cause for the reported event could not be determined.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." h11: h6(method, result, conclusion).H11: section a through f: the information provide by bd represents all 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.

Manufacturer Narrative

H10: the fda rn number for the mdrwas inadvertently submitted as 2020394.The correct fda rn number was 1018233.H10: manufacturing review: a device history review review could not be performed as the lot number is unknown.Investigation summary: the sample was returned for evaluation and photo was provided and reviewed.Based on the photo provided, the investigation is confirmed for detached spring; however, the reported condition was not duplicated during evaluation of the actual sample.A definite root cause for the reported event could not be determined.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." h10: g3.H11: section a through f ¿ the information provide by bd represents all 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.H3 other text : see h10.

Event Description

It was reported that the l spring attached to the seed cartridge allegedly detached from the groove and could not be loaded into the carriage.It was further reported that the seeds were taken out one by one to deal with it.There was no reported patient injury.

• Brand Name: IODINE QL STERILE 13.1MB
• Type of Device: BRACHYTHERAPY LINKS AND CARTRIDGES
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• MDR Report Key: 10815741
• MDR Text Key: 215489394
• Report Number: 2020394-2020-20401
• 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,Followup,Followup
• Report Date: 05/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• 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: 11/11/2020
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other