MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 QUICKLINK EXTENSION LINK #20 SAMPLES; BRACHYTHERAPY LINKS & CARTRIDGES

Model Number 70303QC20

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2021

Event Type  malfunction  

Event 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.

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: 03/2022).

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 19 extension links, was returned from the customer for evaluation.The links in the cartridge were in great shape.The cartridge with the 19 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 was 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: 03/2022).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.

Event 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.

• Brand Name: QUICKLINK EXTENSION LINK #20 SAMPLES
• Type of Device: 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: 13419890
• MDR Text Key: 286370987
• Report Number: 1018233-2022-00309
• Device Sequence Number: 1
• Product Code: KXK
• UDI-Device Identifier: 10801741078115
• UDI-Public: (01)10801741078115
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K023210
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70303QC20
• Device Catalogue Number: 70303QC20
• Device Lot Number: BBFV0046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male