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U.S. Department of Health and Human Services

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

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BARD BRACHYTHERAPY, INC. -1424526 I125 SEEDS IN QUICKLINK CARTRIDGE SINGLE, STERILE; BRACHYTHERAPY LINKS & CARTRIDGES Back to Search Results
Catalog Number 1251QCS
Device Problem Component Misassembled (4004)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/22/2024
Event Type  malfunction  
Event Description
It was reported that during a brachytherapy procedure, the cartridge counters were allegedly inaccurate as there were allegedly eleven seeds in a cartridge which was supposed to have only ten seeds.There was no patient contact.
 
Manufacturer Narrative
H10: 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.H11: section a through f - the information provided by bd represents all of 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 : device pending return.
 
Manufacturer Narrative
H10: additional information was received, the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: g3 h11: b5 h11: section a through f ¿ the information provided 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.Device pending return.
 
Event Description
It was reported that prior to a brachytherapy procedure, the cartridge counters were allegedly inaccurate as there were allegedly eleven seeds in a cartridge which was supposed to have only ten seeds.There was no patient contact.
 
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Brand Name
I125 SEEDS IN QUICKLINK CARTRIDGE SINGLE, 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
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key18738391
MDR Text Key336088826
Report Number1018233-2024-00819
Device Sequence Number1
Product Code KXK
UDI-Device Identifier00801741078354
UDI-Public(01)00801741078354
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1251QCS
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/22/2024
Initial Date FDA Received02/20/2024
Supplement Dates Manufacturer Received02/22/2024
Supplement Dates FDA Received03/21/2024
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 Number1
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