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

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.

• 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 Key: 10229390
• MDR Text Key: 197918947
• Report Number: 2020394-2020-04210
• 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,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 Number: 1251LINK
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 07/03/2020
• Supplement Dates Manufacturer Received: 07/30/2020; 04/15/2021
• Supplement Dates FDA Received: 08/27/2020; 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1