MAUDE Adverse Event Report: CARDINAL HEALTH NEEDLELESS PRECISION 400 U M; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	7000
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Codes	Pain (1994); Discomfort (2330)
Date of Event	11/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported on (b)(6) 2023, in the multi-purpose intensive care unit, it was found the urine was not flowing on a 74 year old.This incident caused discomfort and pain to the patient and put them at risk of urinary globes.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
H4 device manufacture date has been added.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was not received for the investigation.One digital image was received for evaluation.Upon reviewing the image, the reported condition could not be confirmed.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluation to confirm the issue and a possible root cause.At this time, an action plan is not deemed necessary.However, as a containment measure, staff were notified of the reported condition to raise awareness.If additional information is obtained, the complaint will be re-opened for further investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: NEEDLELESS PRECISION 400 U M
• Common Device Name: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 18192723
• Report Number: 9612030-2023-03870
• Device Sequence Number: 7321548
• Product Code: KNX
• UDI-Device Identifier: 10884521002173
• UDI-Public: 10884521002173
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2024

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
• Device Model Number: 7000
• Device Catalogue Number: 7000
• Device Lot Number: 2309402864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2023
• Supplement Date Received by Manufacturer: 11/16/2023
• Initial Report FDA Received Date: 11/22/2023
• Supplement Report FDA Received Date: 02/08/2024
• Date Device Manufactured: 04/11/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Sex: Unknown