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

Catalog Number	1251QCS
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Additional 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 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.H3 other text : device not returned.
Event or Problem Description
It was reported that during brachytherapy procedure, the certificate supplied in the envelope allegedly did not bear the same information as the certificates stuck on and inside the box of iodine grains.There was no reported patient injury.
Event or Problem Description
It was reported that during brachytherapy procedure, the certificate supplied in the envelope allegedly did not bear the same information as the certificates stuck on and inside the box of iodine grains.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record review was performed for the affected lot number of the cartridge and links.No issues were noted.Investigation summary: the sample was not returned for evaluation.Therefore, the investigation is inconclusive for the reported issue.The definitive root cause could not be determined based upon available information.Labeling review: labeling was reviewed and found to be inadequate based off the report from the customer.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.

• Brand Name: I125 SEEDS IN QUICKLINK CARTRIDGE SINGLE, STERILE
• Common Device Name: 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 Key: 17434753
• Report Number: 1018233-2023-05666
• Device Sequence Number: 15674665
• Product Code: KXK
• UDI-Device Identifier: 00801741078354
• UDI-Public: (01)00801741078354
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 1251QCS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 08/04/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 08/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown