MAUDE Adverse Event Report: CARDINAL HEALTH CURITY MONO-FLO 14FR WO PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6162MF
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the balloon was tested by injecting water into the balloon via syringe before the catheter was inserted into the patient.The water wouldn't return to the syringe.
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.
Additional Manufacturer Narrative
Investigation: 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.All associated lot documentation was carefully reviewed.No issues or discrepancies were found related to the reported complaint.No non-conformities nor deviations were reported for this lot.A sample analysis could not be performed because no photo or actual sample was received for evaluation.The complaint will be reopened if sample is received.The reported condition could not be confirmed.Based on the present information the reported issue could not be confirmed to be related to the manufacturing process.A root cause and action plan could not be determined without a sample to evaluate.The current process controls are executed in accordance with product specifications to meet quality acceptance criteria.The manufacturing site will continue to monitor the process, customer complaints and feedback notifications for any adverse trends that require immediate attention.In case of a repeated issues and/or recurrence, a new investigation for the specific event would be carried out for each case.
Additional Manufacturer Narrative
Additional information h4 manufacture date added h3 evaluation summary the device history record (dhr) was reviewed, and this product was manufactured according to the established device master record.No deviation noted on all processing material and parameters.All quality control inspection criteria had been fulfilled satisfactorily.A sample was received and a visual inspection of the received sample was carried out according to the procedure.The balloon was inflated and deflated without problems.The catheter valve, when connecting the syringe, presented a certain pressure that prevents the syringe from connecting correctly to the catheter valve.The sample was forwarded to the supplier for evaluation.The sample was received at the supplier¿s site for evaluation and was physically inspected.No abnormalities were found.During investigation, the sample was subjected to an inflation test whereby 10ml water had been used as recommended in the specification.The balloon was able to be inflated and deflated normally as per its intended functions.No leakage was observed.Water from the balloon can be drained through the inflation channel smoothly and without blockage.The inflated catheter was also tested for its drainability.The catheter can be drained smoothly without blockage.The reported condition unable to be replicated.Thus, no manufacturing fault was found.No problem or abnormality was found.The reported condition was unable to be replicated.No manufacturing fault was found.No actions are necessary at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: CURITY MONO-FLO 14FR WO PVPI
• Common Device Name: COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER
• 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: 13052112
• Report Number: 9612030-2021-03124
• Device Sequence Number: 11139582
• Product Code: KNX
• UDI-Device Identifier: 10884521050587
• UDI-Public: 10884521050587
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/08/2022

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: 6162MF
• Device Catalogue Number: 6162MF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 12/13/2021; 12/13/2021
• Initial Report FDA Received Date: 12/21/2021
• Supplement Report FDA Received Date: 01/25/2022; 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown