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	Obstruction of Flow (2423)
Health Effect - Clinical Code	Urinary Retention (2119)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported, if you don't put it on the ground, the urine stagnates in the bladder and doesn't go down into the box.
Additional Manufacturer Narrative
The device history record (dhr) could not be performed because the lot number was not available.A sample evaluation could not be performed because no sample nor photo were available.The reported condition could not be confirmed.A root cause could not be determined.A walkthrough was carried out of the manufacturing process.Current process and controls were found to be followed correctly.Staff were notified of the reported condition with the purpose of raising staff awareness.The manufacturing site will continue to monitor customer complaint and feedback notifications for adverse trends that require immediate attention.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: 16712793
• Report Number: 9612030-2023-03672
• Device Sequence Number: 1649570
• 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): 05/26/2023

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
• 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: 04/06/2023
• Supplement Date Received by Manufacturer: 04/06/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 05/26/2023
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown