MAUDE Adverse Event Report: BARD BRACHYTHERAPY, INC. -1424526 QUICKLINK¿ CARTRIDGE 5.0MM EXTENSION SOURCELINK¿; CONNECTOR

Model Number	70303QC20
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	10/23/2018
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.The device was not returned.
Event or Problem Description
It was reported that the doctor used an expired extension connector on the patient.The shelf-life of the connector was 200 days ago and the user used the connector 60 days after the expiration.It was later reported from (b)(6) representative on (b)(6) 2018, the customer did not receive the connectors expired.The connectors expired at the facility and the doctor mistakenly used them.
Additional Manufacturer Narrative
The reported issue was confirmed, as use-related.The customer saved connectors at their facility and mistakenly used them during an implant, not realizing the expiration date was exceeded by 60 days.The customer confirmed they did not receive the connections expired from the manufacturing facility.Based on the information contained within this complaint file, it was concluded that the labeling was adequate.The lot number is unknown; therefore, the device history record could not be reviewed.: the device was not returned.
Event or Problem Description
It was reported that the doctor used an expired extension connector on the patient.The shelf-life of the connector was 200 days ago and the user used the connector 60 days after the expiration.It was later reported from the international business center representative on 02nov18, the customer did not receive the connectors expired.The connectors expired at the facility and the doctor mistakenly used them.

• Brand Name: QUICKLINK¿ CARTRIDGE 5.0MM EXTENSION SOURCELINK¿
• Common Device Name: CONNECTOR
• Manufacturer (Section D): BARD BRACHYTHERAPY, INC. -1424526; 295 east lies road; carol stream IL 60188
• MDR Report Key: 8081970
• Report Number: 1018233-2018-05497
• Device Sequence Number: 13994497
• Product Code: KXK
• UDI-Device Identifier: 10801741078115
• UDI-Public: (01)10801741078115
• 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: distributor,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2019

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: 70303QC20
• Device Catalogue Number: 70303QC20
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 12/28/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 01/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1