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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 IODINE SOURCE CAP CARTRIDGE STERILE; BRACHYTHERAPY LINKS & CARTRIDGES
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BARD BRACHYTHERAPY, INC. -1424526 IODINE SOURCE CAP CARTRIDGE STERILE; BRACHYTHERAPY LINKS & CARTRIDGES Back to Search Results
Catalog Number 1251CSF1
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2022
Event Type  malfunction  
Event Description
It was reported that during a brachytherapy procedure, the last two seeds of the device allegedly could not be discharged from the loader.It was further reported that one of the seeds were ejected by pushing the plunger but seed from the other cartridge failed to eject.The last seed was removed from applicator by flipping and shaking the plunger.There was no reported patient injury.
 
Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.
 
Event Description
It was reported that during a brachytherapy procedure, the last two seeds of the device allegedly could not be discharged from the loader.It was further reported that one of the seeds were ejected by pushing the plunger but seed from the other cartridge failed to eject.The last seed was removed from applicator by flipping and shaking the plunger.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: a device history record review was performed for the affected lot number of the cartridge raw material and seeds.These lot met all release criteria.No issues were noted.Investigation summary: one modified mick-15 cartridge was returned from the customer for evaluation and was labeled as biohazardous.The cartridge was inspected and nothing unusual was noted on the outside.The modified mick -15 cartridge was loaded with 15 non-radioactive brachyseeds / sourcecaps and were inserted into a mick applicator.All 15 non-radioactive brachyseeds / sourcecaps from the cartridge dispensed as expected.Upon completion of dispensing, the cartridge was removed from the applicator and examined.Nothing unusual was noted.Therefore, the investigation is not confirmed for the reported issue.A definitive root cause could not be determined based upon the available information.Labeling review: labeling was reviewed and found to be adequate.The instruction for use was reviewed for modified mick 15.There is a warning section stating how to handle the magazine when loaded with seeds as well as warning of over tightening the magazine head to the base.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.
 
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Brand Name
IODINE SOURCE CAP CARTRIDGE STERILE
Type of Device
BRACHYTHERAPY LINKS & CARTRIDGES
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 Key13492972
MDR Text Key285370959
Report Number1018233-2022-00488
Device Sequence Number1
Product Code KXK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K140856
Number of Events Reported1
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 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1251CSF1
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/24/2022
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 Number1
Patient SexMale
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