MAUDE Adverse Event Report: CARDINAL HEALTH CURITY ANTI-RFL 16 FR WO PVPI; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number 8946MF

Device Problem No Flow (2991)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2022

Event Type  malfunction  

Event Description

Customer reports: when the catheter was inserted to the patient, urine wouldn't come out.Once the catheter was replaced, urine came out.No patient harm.The customer suspects a problem with the first catheter used.

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.

Manufacturer Narrative

The device history record was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.One decontaminated sample was received for evaluation.A visual inspection of the sample and a functional test of the received device was conducted according to the product specification procedure.The evaluation concluded that the reported issue could not be confirmed because the condition was not observed in the sample device.In addition, according to the results of the functional test, there was no difficulty observed in the flow of the fluid through the catheter and the drainage tube of the bag.The condition reported by the customer could not be duplicated or confirmed on the returned sample therefore, no action plan is deemed required.The current process is running according to product specifications meeting quality acceptance criteria.We will continue monitoring the process for any adverse trends that require immediate attention.

• Brand Name: CURITY ANTI-RFL 16 FR WO PVPI
• Type of Device: 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 ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13225429
• MDR Text Key: 283606099
• Report Number: 9612030-2022-03134
• Device Sequence Number: 1
• Product Code: KNX
• UDI-Device Identifier: 10884521050655
• UDI-Public: 10884521050655
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8946MF
• Device Catalogue Number: 8946MF
• Device Lot Number: 2107434864
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1