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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported the foley catheter easily came apart from the drainage tubing.There was no harm to the patient.
Additional Manufacturer Narrative
The device history record (dhr) could not be performed because no lot number was not available.A sample analysis could not be done because there were no samples or digital image submitted for evaluation.The complaint will be reopened if a sample is received.The reported condition could not be confirmed.A root cause could not be determined.However, due to similar cases being reported previously for catheter detachment, a corrective and preventative action (capa) was opened 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
• 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: 12814159
• Report Number: 9612030-2021-03091
• Device Sequence Number: 14830752
• Product Code: FFG
• UDI-Device Identifier: 10884521066984
• UDI-Public: 10884521066984
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

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
• Device Model Number: P4P16XTSD
• Device Catalogue Number: P4P16XTSD
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 11/11/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 12/29/2021
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown