MAUDE Adverse Event Report: CARDINAL HEALTH UNKNOWN UROLOGY; CATHETER, RETENTION TYPE, BALLOON

Model Number UNKNOWN UROLOGY

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/31/2021

Event Type  malfunction  

Manufacturer Narrative

Product item code was not provided; however, pro code selected based on the information provided in the event description.Product id was not provided; the udi could not be identified at this time.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.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Per customer, there was a spontaneous separation of tubing from urine meter.A (b)(6) year-old female patient with post open-heart surgery was using 16fr urine meter.On (b)(6) 2021, the device was inserted for open-heart surgery in the operating room (or).On (b)(6) 2021, the patient rolled over in bed and the catheter was dislodged from the bag, right at the site of the green tape.As a result, the patient¿s therapy was interrupted and there was an extensive amount of urine in the patient¿s bed.The patient needs to be monitored closely for intake-output and this was not possible due to the product malfunction.Additional information was received and stated that the interruption of therapy was the inability to measure the patient¿s output, which was part of the regimen.The clinicians assert that the measurement of input and output is crucial, and they were not able to do that due to the reported issue.The patient was not harmed.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A sample was not received for the investigation.Per customer, the sample was discarded.Because a sample was not returned, we were unable to perform a follow-up investigation to include functional and visual evaluations to confirm the issue and root cause analysis.However, there have been complaints reported in the past for catheter detachment.As part of continuous improvements, a corrective action (capa) has been opened to address the reported issue through a more robust investigation.The results of investigation will be documented through the referred capa.

• Brand Name: UNKNOWN UROLOGY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• 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: 12783045
• MDR Text Key: 281673456
• Report Number: 9612030-2021-03083
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

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 Operator: Health Professional
• Device Model Number: UNKNOWN UROLOGY
• Device Catalogue Number: UNKNOWN UROLOGY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/09/2021
• Supplement Dates Manufacturer Received: 11/01/2021
• Supplement Dates FDA Received: 11/11/2021
• 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
• Patient Age: 51 YR
• Patient Sex: Female