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	09/22/2021
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 that the foley catheter dislodged from the tubing.
Additional Manufacturer Narrative
Two decontaminated drainage bags with date code 119-0d62 were received at the manufacturing site for evaluation.According to the date code printed on both bags, they correspond to product code p4p16xts and lots 2010524064 and 2010524164 which were manufactured on april 28, 2020.The samples do not correspond to the product information reported: p4p16xtsd and lot 2113141764.The device history records were reviewed, and no abnormal process conditions were present during the manufacturing of the products that could have led to the issue reported.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The samples were both visually and functionally inspected per procedure.Both samples were received with the catheters connected to the bag adapters, the detachment of the catheters were not visually observed.A tension test was then performed, the minimum acceptable specification is 6 lbs.For silicone catheters, the results of the tests were 9.63 lbs.And 7.23 lbs.The catheter-to-adapter stress test specifications were acceptable.The reported issue could not be confirmed at this time.However, as part of continuous improvements, a corrective and preventive action (capa) has been initiated to further investigate and address the report of catheter detachments through a more robust investigation.The results of that investigation will be documented through the capa.

• 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: 12583715
• Report Number: 9612030-2021-03052
• Device Sequence Number: 16467910
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2022

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
• Device Lot Number: 2113141764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 09/23/2021
• Initial Report FDA Received Date: 10/06/2021
• Supplement Report FDA Received Date: 01/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown