MAUDE Adverse Event Report: CARDINAL HEALTH FOLY CATH 100 SLCON 5CC 18FR; CATHETER, RETENTION TYPE, BALLOON

Model Number	8887605189
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the conical end of the catheter was missing.Per customer, the catheter was put into the patient, and it was during surgery that they noticed that conical end was missing.The surgeon removed the catheter from the patient and put another one in, to complete the surgery.The surgeon did several manipulations to find the end of the catheter in the abdomen but without success and to complete the surgery he did a cystoscopy and found nothing either.The customer further stated that maybe there was no conical end before the insertion, but they cannot confirm it.Additional information was received and stated that the patient had robotic radical prostatectomy surgery and during the surgery they noticed that conical end of the catheter was missing.The cystoscopy procedure was performed to find the missing conical end, because this procedure is not usually done after a prostatectomy.Per customer, at the time of the incident the patient was doing fine.
Additional Manufacturer Narrative
Initial reporter e-mail: (b)(6).An investigation is currently underway.Upon completion, the results will be forwarded.
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 product.The product was manufactured on 06-feb-2020.Two pictures were provided for analysis.Upon reviewing the pictures, the reported issue was confirmed.One used sample was received for the evaluation.Upon visual and functional evaluation, missing tip was observed.Tests were carried out to replicate the reported issue.The tests showed a manipulated part which was what placed under the fuji sealing machine.The sealer concavely cuts the catheter and causes damage to the pouch.Through the test, it was seen that the catheter was cut / torn off one millimeter above where the tip is molded.Therefore, the tip did not come off the point of union / molding.The issue cannot be determined as a manufacturing issue since all the pieces are 100% examined.The probable root cause could be related to catheter manipulation.Based on the investigation performed, no definitive root cause could be determined.A quality alert will be issued to notify the personnel about the reported issue.This complaint will be used for tracking and trending purposes.

• Brand Name: FOLY CATH 100 SLCON 5CC 18FR
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16246280
• Report Number: 1282497-2023-10729
• Device Sequence Number: 6605675
• Product Code: EZL
• UDI-Device Identifier: 20884521016702
• UDI-Public: 20884521016702
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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
• Operator of Device: Health Professional
• Device Model Number: 8887605189
• Device Catalogue Number: 8887605189
• Device Lot Number: 2003113
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 01/16/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown