MAUDE Adverse Event Report: CARDINAL HEALTH P400 PREM U/M 16FR SL TMP CSD; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Model Number	P4P16XTSD
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation. if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted. as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
Customer reports: the catheter disconnected.
Additional Manufacturer Narrative
Additional information: h4 device manufacture date added h6 health effect - clinical code and health effect - impact code added the device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported condition.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.A sample analysis not applicable because there were no samples or digital image submitted with this complaint.The complaint will be reopened if a sample is received.The reported condition could not be confirmed.Because no samples or photos were received for evaluation, the condition reported could not be confirmed; however, there have been cases reported in the past for catheter detachment, of which a corrective and preventative action (capa) was opened in order to address the reported condition through a more robust investigation.Results of the investigation will be documented through this capa.This complaint will be used for tracking and trending purposes.

• Brand Name: P400 PREM U/M 16FR SL TMP CSD
• Common Device Name: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• Manufacturer (Section D): CARDINAL HEALTH; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 12183935
• Report Number: 9612030-2021-02989
• Device Sequence Number: 4370938
• Product Code: FFG
• UDI-Device Identifier: 10884521066984
• UDI-Public: 10884521066984
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: No Information
• Device Model Number: P4P16XTSD
• Device Catalogue Number: P4P16XTSD
• Device Lot Number: 2025100664
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 07/14/2021
• Initial Report FDA Received Date: 07/16/2021
• Supplement Report FDA Received Date: 09/01/2021
• Patient Sequence Number: 1