MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 I125 QUICKLINK CARTRIDGE STERILE; BRACHYTHERAPY LINKS & CARTRIDGES

Model Number	1251QCS
Medical Device Problem Codes	Inadequate Instructions for Healthcare Professional (1319); Inadequate Instructions for Non-Healthcare Professional (2956)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that prior to a procedure, the device was delivered to the general warehouse of the hospital instead of the radiophysics service.There was no patient contact.
Event or Problem Description
It was reported that prior to a procedure, the device was delivered general warehouse of the hospital instead of in the radiophysics service.There was no patient contact.
Additional Manufacturer Narrative
H10: the previous report was submitted with an incorrect fda site registration number.The correct fda site registration number is 1018233.H10: manufacturing review: a sales order and device history record (dhr) review was performed for the affected lot number of the product.No issues were noted.Investigation summary: a review of the event determined that the third party supplier who handles transport of this product made an error in delivery.Although this event does not fit the definition of a product complaint, the investigation was completed and is confirmed with a root cause failure to follow instructions by the supplier.Corrective actions were implemented by making sure all of the third party supplier drivers have copy of current delivery procedure with the correct hospital address and department.Labeling review: there was no need of labeling review, since no issue was identified nor reported with the product.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.
Additional Manufacturer Narrative
H10: the fda rn number for the mdr 2020394-2021-00570 was inadvertently submitted as 2020394.The correct fda rn number was 1018233.H10: manufacturing review: a sales order and device history record (dhr) review was performed for the affected lot number of the product.No issues were noted.Investigation summary: a review of the event determined that the third party supplier who handles transport of this product made an error in delivery.Although this event does not fit the definition of a product complaint, the investigation was completed and is confirmed with a root cause failure to follow instructions by the supplier.Corrective actions were implemented by making sure all of the third party supplier drivers have copy of current delivery procedure with the correct hospital address and department.Labeling review: there was no need of labeling review, since no issue was identified nor reported with the product.H10: g3.H11: d2 (common device name), h6 (device).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.H3 other text : device not returned.
Event or Problem Description
It was reported that prior to a brachytherapy procedure, the device was delivered to general warehouse of the hospital instead of in the radiophysics service.There was no patient contact.

• Brand Name: I125 QUICKLINK CARTRIDGE STERILE
• Common Device Name: BRACHYTHERAPY LINKS & CARTRIDGES
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• Manufacturer (Section G): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream 60188
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 11492223
• Report Number: 2020394-2021-00570
• Device Sequence Number: 5373973
• Product Code: KXK
• UDI-Device Identifier: 00801741078354
• UDI-Public: (01)00801741078354
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K093663
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/08/2022

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: 1251QCS
• Device Catalogue Number: 1251QCSCE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/19/2021; 03/02/2022
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/12/2021; 03/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown