• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 IODINE 125 SEEDS IN QUICKLINK , STERILE, 13.1 MBQ; BRACHYTHERAPY LINKS & CARTRIDGES

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD BRACHYTHERAPY, INC. -1424526 IODINE 125 SEEDS IN QUICKLINK , STERILE, 13.1 MBQ; BRACHYTHERAPY LINKS & CARTRIDGES Back to Search Results
Catalog Number 1251QCL2
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/02/2021
Event Type  malfunction  
Event Description
It was reported that during a brachytherapy procedure, the device packaging allegedly unsealed.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 device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.
 
Manufacturer Narrative
H10: manufacturing review: a device history record review was not performed.The reported product code is not designated with a lot number investigation summary: the sample was not returned to the location.However, photo was provided for review.The photo shows that the tamper evident label was missing on the secondary container d.Based on the evidence, the investigation is confirmed for reported issue and the root cause is manufacturing related.Labeling review: labeling was reviewed and found to be adequate.The information for use was reviewed.There is a caution statement, which states "do not use if the package is damaged" and also "do not re-sterilize".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 not returned.
 
Event Description
It was reported that during a brachytherapy procedure, the device packaging allegedly unsealed.There was no reported patient injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
IODINE 125 SEEDS IN QUICKLINK , STERILE, 13.1 MBQ
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 Key12880992
MDR Text Key284813140
Report Number1018233-2021-07537
Device Sequence Number1
Product Code KXK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K093663
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,Followup
Report Date 12/09/2021
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 Number1251QCL2
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/02/2021
Initial Date FDA Received11/29/2021
Supplement Dates Manufacturer Received12/09/2021
Supplement Dates FDA Received12/13/2021
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
-
-