MAUDE Adverse Event Report: BRACHYSOURCE I-125 SEEDS IN QUICKLINK CARTRIDGE SINGLE, STERILE; BRACHYTHERAPY SEEDS

Catalog Number 1251QCS1

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

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

Event Date 08/23/2021

Event Type  malfunction  

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.

Event Description

It was reported that prior to the procedure, the outer box was allegedly damaged and dirt was attached.There was no patient contact.

Event Description

It was reported that prior to the procedure, the outer box was allegedly damaged and dirt was attached.There was no patient contact.

Manufacturer Narrative

H10: manufacturing review: as the lot number for the device was not provided, a review of the device history records could not be performed.Investigation summary: the sample was not returned for evaluation; however, photos were provided for review.Therefore, the investigation is confirmed for damaged outer box, based on the picture provided.The alleged defect noted could potentially be caused due to moisture damage after sterilization, during shipping or storage.The definitive root cause could not be determined based upon available information.Labeling review: labeling was reviewed and found to be adequate.There is a caution statement for storage requirements in information for use: "extra care should be taken to avoid exposing the quicklink cartridges containing bio absorbable sourcelink components to excessive heat or moisture.Store unopened packages at room temperature.Discard open, unused cartridges, sourcelink connectors, and sourcelink spacers." h10: g3.H11: e1, h6 (method, result, conclusion).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: BRACHYSOURCE I-125 SEEDS IN QUICKLINK CARTRIDGE SINGLE, STERILE
• Type of Device: BRACHYTHERAPY SEEDS
• MDR Report Key: 12518396
• MDR Text Key: 272873700
• Report Number: 1018233-2021-05891
• Device Sequence Number: 1
• Product Code: KXK
• Combination Product (y/n): N
• PMA/PMN Number: K093663
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1251QCS1
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/12/2021
• 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 Number: 1