MAUDE Adverse Event Report: CARDINAL HEALTH, INC. DOVER; SYRINGE, IRRIGATING (NON DENTAL)

Model Number	68820
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Unspecified Infection (1930)
Date of Event	12/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G2 report source: other source has been checked and medwatch # mw5160967 has been added.
Event or Problem Description
Per customer, the patient (his wife) had cancer, and was using a urinary catheter, that required the use of sterile saline, and products associated with nurse assist tray.In 2023, patient¿s at-home nurse replaced her catheter using one of the nurse assist trays that turned out to be the part of a product recall.The next day his wife had a fever, and she had to be hospitalized.She was diagnosed with an infection caused by contamination from the nurse assist kit.Per customer, he did not receive a letter about the recall until 2024, and his wife died in 2024.At this time the cause of death is unknown, and it was unknown if there was any correlation between the reported incident and the patient¿s death.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record for lot 2312920864 was reviewed and no anomalies related to the reported issue were observed.There were no photos or physical samples received for evaluation.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.Based on this information, no corrective actions are warranted at this time.We will continue to track and trend through our monitoring programs and take actions as applicable.

• Brand Name: DOVER
• Common Device Name: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH, INC.; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20567168
• Report Number: 1423537-2024-00275
• Device Sequence Number: 8502799
• Product Code: KYZ
• UDI-Device Identifier: 10884521008311
• UDI-Public: (01)10884521008311(17)250206(10)2312920864
• Combination Product (Y/N): N
• Initial Reporter State: CA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 02/02/2025
• Device Model Number: 68820
• Device Catalogue Number: 68820
• Device Lot Number: 2312920864
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 10/30/2024; 12/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Other
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic