MAUDE Adverse Event Report: CARDINAL HEALTH PRECISION PRM 16FR SIL COUDE CSD; COLLECTOR, URINE, (AND ACCESSORIES) FOR INDWELLING CATHETER

Model Number	PP16CSD
Medical Device Problem Code	Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
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 balloon burst almost immediately after inserting the catheter.There was no patient injury.
Additional 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 the release of product.There were no photos or physical samples received for evaluation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition or determine the root cause.A gemba was carried out in the manufacturing process.Current process and controls were found to be followed correctly, including subassemblies, finished product assembly, packaging, and product inspections.The research was carried out with the multifunctional team.All the processes were reviewed, and it was verified that all the processes and controls were carried out correctly, including the packaging and all the inspections carried out on the product.No abnormal conditions were found that could trigger the reported condition.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.Staff has been notified of the reported condition with the purposes of raising awareness.We will continue to monitor customer complaints and feedback notifications for adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: PRECISION PRM 16FR SIL COUDE CSD
• 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: 18238905
• Report Number: 9612030-2023-03875
• Device Sequence Number: 7152525
• Product Code: KNX
• UDI-Device Identifier: 10884521143364
• UDI-Public: 10884521143364
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2023

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: PP16CSD
• Device Catalogue Number: PP16CSD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 12/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown