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 Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/09/2018
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.Bm (b)(4) is associated with this event.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the facility received seeds with product code (b)(4) (sales order (b)(4)) that were intended for a different facility, instead of the seeds that were ordered (1251csr and 1251csra - sales order (b)(4)).The initial investigation into the issue indicates that the fedex labels on the outer shipping boxes were switched.The seeds that the facility received ((b)(4)) were reportedly used on the patient and the patient received the correct dosage without impact.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of this complaint was a result of switched shipping documentation at bbi when the affected orders were being packaged and shipped.Bb-capa-18-010 was initiated to further investigate this issue.There is no lot number for the product code alleged by the customer, therefore, a device history record review could not be performed.The instructions for use state the following: "established practice 11,12,16,17,19 should be followed for the calculation of the total activity to be implanted, the evaluation of the radiation dose distribution and the proper placement of the brachysource® seed implants with sourcecaptm bioabsorbable caps within the tissue.The tumor volume and the previous radiation history of the tumor site should be considered for the total activity calculation for any given treatment.The anisotropy should be considered in dose calculations for treatment planning since dose distribution around each individual brachysource® seed implant with sourcecaptm bioabsorbable caps is not isotropic, as with other i-125 brachytherapy sources.3,4,5,15,18 i-125 has a 59.6 day half life1.Decay corrections must be made to properly calculate" bm-rap-18-04-004 is associated with this event.
Event or Problem Description
It was reported that the facility received seeds with product code ps1251ls (sales order #(b)(4)) that were intended for a different facility, instead of the seeds that were ordered (1251csr and 1251csra - sales order #(b)(4)).The initial investigation into the issue indicates that the fedex labels on the outer shipping boxes were switched.The seeds that the facility received (ps1251ls) were reportedly used on the patient and the patient received the correct dosage without impact.
Event or Problem Description
It was reported that the facility received seeds with product code ps1251ls (sales order # (b)(4)) that were intended for a different facility, instead of the seeds that were ordered (1251csr and 1251csra - sales order #(b)(4)).The initial investigation into the issue indicates that the fedex labels on the outer shipping boxes were switched.The seeds that the facility received (ps1251ls) were reportedly used on the patient and the patient received the correct dosage without impact.
Additional Manufacturer Narrative
The reported issue was confirmed.The root cause of this complaint was a result of switched shipping documentation at bbi when the affected orders were being packaged and shipped.Bb-capa-18-010 was initiated to further investigate this issue.There is no lot number for the product code alleged by the customer, therefore, a device history record review could not be performed.The instructions for use state the following: "established practice11,12,16,17,19 should be followed for the calculation of the total activity to be implanted, the evaluation of the radiation dose distribution and the proper placement of the brachysource® seed implants with sourcecaptm bioabsorbable caps within the tissue.The tumor volume and the previous radiation history of the tumor site should be considered for the total activity calculation for any given treatment.The anisotropy should be considered in dose calculations for treatment planning since dose distribution around each individual brachysource® seed implant with sourcecaptm bioabsorbable caps is not isotropic, as with other i-125 brachytherapy sources.3,4,5,15,18 i-125 has a 59.6 day half life1.Decay corrections must be made to properly calculate" (b)(4) is associated with this event.

• Brand Name: BARD® BRACHYSOURCE® I-125 IMPLANT SEEDS IN CARTRIDGES
• Common Device Name: SEEDS
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 7485823
• Report Number: 1018233-2018-01482
• Device Sequence Number: 11170157
• 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: health professional,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/24/2018

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 05/14/2018; 07/05/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 05/18/2018; 07/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1