MAUDE Adverse Event Report: CARDINAL HEALTH CURITY MONO-FLO 16 FR W O PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	6155MF
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2021
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
The customer reported that anti-reflux device was stuck inside the bag's inner wall when the package was opened and making it difficult for urine to flow through.The issue was noticed during use.There was no patient harm reported.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed, indicating that the product was released, accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality prior to release of the product.The device was manufactured on 02-mar-2021.The investigation was carried out with the multifunctional team.All processes and controls were reviewed.No abnormal conditions were found that could trigger the reported condition.One unused sample was received for the evaluation.Visual and functional inspection was performed and found that the bag was cut from the vinyl in to two parts.In addition, during the functional test, no difficulty was observed for the liquid to flow through the bag's inlet port and the drainage port.The returned sample meets the quality specifications, no issues were observed in the inlet port and the drainage port during the operation of the bag.Therefore, the reported condition could not be confirmed.At this time, corrective and preventive action is not deemed necessary.The current process is running according to product specifications, meeting all quality acceptance criteria.We will keep monitoring the process for any adverse trends that require immediate attention.This complaint will be used for qa tracking and trending purposes.

• Brand Name: CURITY MONO-FLO 16 FR W O 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: 12619261
• Report Number: 9612030-2021-03059
• Device Sequence Number: 14321086
• Product Code: KNX
• UDI-Device Identifier: 10884521050549
• UDI-Public: 10884521050549
• 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): 01/19/2022

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: 6155MF
• Device Catalogue Number: 6155MF
• Device Lot Number: 2104826364
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 10/12/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown