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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. BRACHYSOURCE I-125 SEED - SEED WITH SEEDLINK CONNECTORS; BRACHYTHERAPY

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BARD BRACHYTHERAPY, INC. BRACHYSOURCE I-125 SEED - SEED WITH SEEDLINK CONNECTORS; BRACHYTHERAPY Back to Search Results
Catalog Number 1251LINK
Device Problems Component Missing (2306); Appropriate Term/Code Not Available (3191)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2020
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 11/2020).
 
Event Description
It was reported that prior to a brachytherapy procedure, the device allegedly found to had less number seeds and extra space.
 
Manufacturer Narrative
H10: as the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.
 
Event Description
It was reported that prior to a brachytherapy procedure, the device allegedly found to had extra spacers.The procedure was completed using same device.There was no reported patient injury.
 
Manufacturer Narrative
H10: the fda rn number for the mdr 2020394-2020-04210 was inadvertently submitted as 2020394.The correct fda rn number was 1018233.As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: g3.H11: e3,h6(method).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.
 
Event Description
It was reported that prior to a brachytherapy procedure, the device allegedly found to had extra spacers.The procedure was completed using same device.There was no reported patient injury.
 
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Brand Name
BRACHYSOURCE I-125 SEED - SEED WITH SEEDLINK CONNECTORS
Type of Device
BRACHYTHERAPY
Manufacturer (Section D)
BARD BRACHYTHERAPY, INC.
295 east lies road
carol stream IL 60188
MDR Report Key10229390
MDR Text Key197918947
Report Number2020394-2020-04210
Device Sequence Number1
Product Code KXK
Combination Product (y/n)N
PMA/PMN Number
K093663
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1251LINK
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/09/2020
Initial Date FDA Received07/03/2020
Supplement Dates Manufacturer Received07/30/2020
04/15/2021
Supplement Dates FDA Received08/27/2020
05/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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