MAUDE Adverse Event Report: CARDINAL HEALTH P400 PREM U/M 16FR CATH SECURE; DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE

Model Number	P4P16SD
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that a foley catheter was inserted with kit by the medical doctor (md) at the start of the procedure.During the procedure, approximately 20 minutes after inserting laparoscopic ports, there was an audible pop sound.The md stopped the procedure and the staff checked the patient and surroundings.The md also visually checked the patient's abdominal cavity with a scope.No areas of injury or noted concerns.At the end of the procedure, the md went to remove the foley.Upon pulling back the balloon fluid, they noted urine in return.The foley was removed with a noted rip in the balloon.A cystoscopy was done with no appearance of retained product.Sample is not available to be returned however a photo is attached.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
One digital image was provided for evaluation.A visual inspection of the digital image was performed and the reported issue was confirmed; the balloon has a rip.The device history records were reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to this issue.The device history record review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The balloons undergo 100% inspection by inflation to nominal volume as well as a visual inspection for irregularities which may cause early failure.The controls which are put in place for this type of failure were followed properly.Retained samples were evaluated and no problems were found.Based on the available information, we were unable to detect any non-conformities during our investigation and an exact root cause was unable to be determined.The silicone balloons may fail due to user-related reasons like over-inflation or pulling.At this time, no corrective actions are necessary.This complaint will be used for tracking and trending purposes.

• Brand Name: P400 PREM U/M 16FR CATH SECURE
• Common Device Name: DEVICE, URINE FLOW RATE MEASURING, NON-ELECTRICAL, DISPOSABLE
• 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: 13572880
• Report Number: 9612030-2022-03170
• Device Sequence Number: 11727438
• Product Code: FFG
• UDI-Device Identifier: 20884521029597
• UDI-Public: 20884521029597
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: P4P16SD
• Device Catalogue Number: P4P16SD
• Device Lot Number: 2119502864
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/04/2022
• Supplement Date Received by Manufacturer: 02/04/2022
• Initial Report FDA Received Date: 02/21/2022
• Supplement Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown