MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 UNKNOWN BRACHYTHERAPY SEEDS

Catalog Number UNK BRACHYTHERAPY SEEDS

Device Problem Unclear Information (4052)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2023

Event Type  malfunction  

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.However, a photo was provided for review.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.

Event Description

It was reported that during preparation of a brachytherapy procedure, the plastic envelope allagedly had another patient/seeds information instead of the original patient/seeds information, which was totally different.There was no patient contact.

Event Description

It was reported that during preparation of a brachytherapy procedure, the plastic envelope allegedly had another patient/seeds information instead of the original patient/seeds information, which was totally different.There was no patient contact.

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: the sample was not returned for evaluation.However, an image was attached to the complaint record showing a different customer courtesy label than that of the customer¿s order.Therefore, the investigation is confirmed for the reported issue.The root cause was determined to be manufacturing related.Labeling review: the customer order documentation was reviewed for any issues related to labeling.Looking at the documentation for both customer orders, all process steps in the batch records were followed and verified.The copy of the labels attached shows that each customer order had the correct labelling during manufacture and customer order verification.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.Device not returned.

• Brand Name: UNKNOWN BRACHYTHERAPY SEEDS
• Type of Device: BRACHYTHERAPY SEEDS
• 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: 18482388
• MDR Text Key: 332741881
• Report Number: 1018233-2023-09572
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• 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: 02/01/2024

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 Number: UNK BRACHYTHERAPY SEEDS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/10/2024
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 02/16/2024
• 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 Number: 1