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

Model Number	1251CSR
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This complaint was confirmed, and the root cause was a customer service order processing error.The device was not returned for evaluation.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: ¿indications brachysource® seed implants are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate.Brachysource® seed implants may be used in superficial, intra-abdominal and intra-thoracic locations.Brachysource® seed implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors.Contraindications as with other brachytherapy sources, treatment of tumors in generally poor condition [e.G.Ulcerated] is not recommended with brachysource® seed implants due to the potential of brachytherapy source migration.Warnings and precautions: warning: brachysource® seed implants contain radioactive materials.Brachysource® seed implants, like all radioactive materials, must be handled with care.Appropriate safety measures should be used to minimize exposure to clinical personnel.Personnel monitoring is required.Typically a film badge or tld dosimeter worn on the body and a ring badge(s) is adequate.Care should be taken to minimize radiation exposure to patients and other individuals consistent with proper therapeutic management.During the implantation procedure, all practical steps should be employed to maintain radioactive exposure as low as reasonably achievable.In circumstances such as surgery when protective barriers are not practical, operators must rely upon proper use of applicators, distance and speed to minimize radiation exposure.7,8,9,10 initiate radiation surveys on all components upon completion of the seed implant.Warning: never implant visibly damaged brachysource® seed implants.Brachysource® seed implants should never be handled roughly or forced into any implant device, cartridge or needle.Such force may damage the wall of the brachytherapy source, potentially causing release of i-125 into the environment or tissues surrounding an implanted." 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 had to be 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: BARD® BRACHYSOURCE® I-125 IMPLANT SEEDS IN CARTRIDGES
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 8425323
• Report Number: 1018233-2019-01344
• Device Sequence Number: 11275476
• Product Code: KXK
• UDI-Device Identifier: 00801741078262
• UDI-Public: (01)00801741078262
• 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
• Report Date (Section B): 03/15/2019

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