MAUDE Adverse Event Report: CARDINAL HEALTH SILICONE 14FR 5CC 2WAY COUDE; CATHETER, UROLOGICAL

Model Number	20514C
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported the urinary catheter fell out onto the patients bed.The catheter was still attached to the drainage bag, but was broken in half with the upper portion of the catheter inside the patient.The patient needed to be admitted and underwent a procedure to remove the retained piece of catheter.The nurse stated that there was no tension on the foley and it was not caught on anything.The patient came in (b)(6) 2023, and the incident happened in the er (b)(6) 2023.The patient was awake and alert when the incident happened, none of the staff heard anything.The patient had received catheters before.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Additional information: h7 medwatch number added a2 age and a3 gender was added.
Additional Manufacturer Narrative
The device history record review of the reported lot number shows evidence that the product was released according to all established procedures and quality documentation.Pictures were provided by the customer.It can be observed from the pictures that the catheter is broken; however, it cannot be confirmed as manufacturing related.The sample is needed for further investigation.The failure mode could not be confirmed.The root cause and corrective actions could not be identified.This complaint will be closed with no further action.If a sample is received later, the complaint will be reopened for investigation.This complaint will be used for tracking and trending purposes.

• Brand Name: SILICONE 14FR 5CC 2WAY COUDE
• Common Device Name: CATHETER, UROLOGICAL
• 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: 18148390
• Report Number: 1282497-2023-10808
• Device Sequence Number: 7541213
• Product Code: KOD
• UDI-Device Identifier: 10884521015944
• UDI-Public: 10884521015944
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/24/2024

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: 20514C
• Device Catalogue Number: 20514C
• Device Lot Number: 2122195
• 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: 11/07/2023
• Supplement Date Received by Manufacturer: 11/07/2023; Not provided
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 12/21/2023; 04/24/2024
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Male