MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 BRACHYSOURCE I-125 IMPLANT SEEDS IN CARTRIDGES; BRACHYTHERAPY LINKS AND CARTRIDGES

Model Number	PS1251CS
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2020
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
It was reported that the product labeling was incorrect.Reportedly, the patient received the proper dosage of radiation.There was no reported patient injury.
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 provide by bd represents all 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 or Problem Description
It was reported that the product labeling was incorrect.Reportedly, the patient received the proper dosage of radiation.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the fda rn number for the mdr mfr report no was inadvertently submitted as 2020394-2021-00011.The correct fda rn number was 1018233.H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.This deviation is not related to the reported condition.Investigation summary: the sample was not returned for evaluation.The investigation is confirmed for component misassembled issue, and the root cause is a customer service order entry error.Labeling review: labeling was reviewed and found to be inadequate.The reference date was indicated as 9-12-2020 when it should have been indicated as 9-5-2020.H10: g3.H11: h6 (method, result, conclusion) h11: section a through f ¿ the information provide by bd represents all 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 the product labeling was incorrect.Reportedly, the patient received the proper dosage of radiation.There was no reported patient injury.

• Brand Name: BRACHYSOURCE I-125 IMPLANT SEEDS IN CARTRIDGES
• Common Device Name: BRACHYTHERAPY LINKS AND CARTRIDGES
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• MDR Report Key: 11127300
• Report Number: 2020394-2021-00011
• Device Sequence Number: 4606922
• Product Code: KXK
• UDI-Device Identifier: 00801741078224
• UDI-Public: (01)00801741078224
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K093663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: PS1251CS
• Device Catalogue Number: PS1251CS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/15/2020
• Supplement Date Received by Manufacturer: 02/05/2021; 04/15/2021
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 03/05/2021; 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other