MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 QUICKLINK¿ LOADER; QUICKLINK LOADER

Catalog Number	70310QCA1
Health Effect - Clinical Code	No Patient Involvement (2645)
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.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 there was a crack in the device.When the hospital wanted to use this quicklink for a procedure, they were not able to turn/fixate the screw because the screw "wire" was torn/damaged.Therefore, the procedure was cancelled by the hospital and the patient was not treated.
Additional Manufacturer Narrative
This complaint was confirmed, and the root cause of the damage was concluded to be a result of stress created during the autoclaving process.During evaluation, broken components were observed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use states the following: ¿the quicklink loader should be inspected for damage prior to use and replaced or repaired as necessary." (b)(4).
Event or Problem Description
It was reported that there was a crack in the device.When the hospital wanted to use this quicklink for a procedure, they were not able to turn/fixate the screw because the screw "wire" was torn/damaged.Therefore, the procedure was cancelled by the hospital and the patient was not treated.

• Brand Name: QUICKLINK¿ LOADER
• Common Device Name: QUICKLINK LOADER
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 6817875
• Report Number: 1018233-2017-04421
• Device Sequence Number: 18846987
• Product Code: IWJ
• UDI-Device Identifier: 00801741079238
• UDI-Public: (01)00801741079238
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2017

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 Catalogue Number: 70310QCA1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Initial Date Received by Manufacturer: 08/03/2017
• Supplement Date Received by Manufacturer: 11/19/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1