MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 BARD® BRACHYSOURCE® I-125 IMPLANT SEEDS IN CARTRIDGES; I-1251 DISPOSIABLE 15 ASSAY

Model Number	1251CSRA
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the seeds were shipped to surgery for urology in (b)(6) instead of (b)(6) medical center in (b)(6).The seeds were driven to (b)(6) medical center from (b)(6) for the scheduled implant.There was a 2-3 hour surgical delay due to the delivery error.However, the patient received their full prescribed dose.
Additional Manufacturer Narrative
The reported event was confirmed, and the root cause was a customer service order processing error.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿instructions for use brachysource® seed implants in mick® cartridges are supplied sterile.During the treatment procedure, the patient must be appropriately anesthetized.A qualified practitioner may place the brachysource® seed implants throughout the tumor volume according to a treatment plan for geometric arrangement.Brachysource® seed implants in cartridges have been designed to be compatible with mick® brachytherapy applicators and needles." the device was not returned.
Event or Problem Description
It was reported that the seeds were shipped to surgery for urology in (b)(6) instead of (b)(6) medical center in (b)(6).The seeds were driven to (b)(6) medical center from (b)(6) for the scheduled implant.There was a 2-3 hour surgical delay due to the delivery error.However, the patient received their full prescribed dose.

• Brand Name: BARD® BRACHYSOURCE® I-125 IMPLANT SEEDS IN CARTRIDGES
• Common Device Name: I-1251 DISPOSIABLE 15 ASSAY
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 8425321
• Report Number: 1018233-2019-01343
• Device Sequence Number: 193424
• Product Code: KXK
• UDI-Device Identifier: 00801741078279
• UDI-Public: (01)00801741078279
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K093663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

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: 1251CSRA
• Device Catalogue Number: 1251CSRA
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 03/15/2019
• Supplement Report FDA Received Date: 04/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1