MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 QUICKLINK SDS LINK #10 SAMPLES; BRACHYTHERAPY LINKS & CARTRIDGES

Model Number	70302QC10
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 05/2022).
Event or Problem Description
It was reported that during a brachytherapy procedure, the seeds allegedly could not be discharged from the loader.There was no reported patient injury.
Event or Problem Description
It was reported that during a brachytherapy procedure, the sourcelinks allegedly could not be discharged from the loader.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot met all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: one quicklink cartridge filled with 9 seed to seed links was returned from the customer for evaluation.The links in the cartridge were in great shape.The cartridge with the 9 links was placed into a quicklink loader and was able to dispense all of the links on the first attempt without any issues.After dispensing the links, the cartridge was inspected and nothing unusual was noted.The cartridge gate closure worked as expected, no spring protrusion on the backside of the cartridge and the plunger traveled appropriately.The investigation is unconfirmed for reported issue, and the root cause is undetermined.Labeling review: labeling was reviewed and found to be adequate.There is a caution statement, which states "in the event the quicklink loader or cartridges become inoperable due to damage or malfunction, any or all components may be removed from the cartridges and implanted manually." h10: d4 (expiry date: 05/2022).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 : see h10.

• Brand Name: QUICKLINK SDS LINK #10 SAMPLES
• 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: 13415600
• Report Number: 1018233-2022-00282
• Device Sequence Number: 4870186
• Product Code: KXK
• UDI-Device Identifier: 10801741078092
• UDI-Public: (01)10801741078092
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K023210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2022

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: 70302QC10
• Device Catalogue Number: 70302QC10
• Device Lot Number: BBFW0063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 02/01/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2021
• 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
• Patient Sex: Male