MAUDE Adverse Event Report: CARDINAL HEALTH CURITY MONO-FLO 18FR WO PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6156MF
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 that the urine accumulated at the connection between the running tube and the bag and did not flow.They drained the urine in the bag and pinched the chamber part of the connection between the bag and running tube, and although it may have flowed a little, they replaced it.There was no patient injury.
Additional Manufacturer Narrative
One decontaminated drainage bag was received at the manufacturing site for investigation.The date code printed on the bag corresponds with item code 6156mf and lot number 2108935464.The device history record was reviewed for lot 2108935464 and indicated that the product was released accomplishing all quality standards.The device was manufactured on april 08, 2021.Visual and functional inspections were performed, and the reported condition could not be confirmed; during the filling of the bag to its maximum capacity (2000 ml), no conditions were observed that prevented the flow of liquid through the pvc tube and the drip chamber into the bag.A gemba was carried out in the manufacturing process.The current process and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.No abnormal conditions were found that could trigger the reported condition.A corrective action is not applicable at this time.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.However, the appropriate staff has been notified of the reported condition with the purposes of raising staff awareness.We will continue to monitor customer complaints and feedback notification for adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: CURITY MONO-FLO 18FR WO PVPI
• 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: 15002206
• Report Number: 9612030-2022-03316
• Device Sequence Number: 1880596
• Product Code: KNX
• UDI-Device Identifier: 10192253059809
• UDI-Public: 10192253059809
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 08/30/2022

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: 6156MF
• Device Catalogue Number: 6156MF
• Device Lot Number: 2108935464
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2022
• Supplement Date Received by Manufacturer: 07/12/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 08/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown