MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. URINARY CATHETER; CATHETER, UROLOGICAL

Model Number	INTS14
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
After completing urinary catheterization on patient, clamp on catheter closed.While removing the bag and catheter from the sterile field, the catheter dislodged itself from the collection bag(no tension was applied).The remaining urine that was in the catheter sprayed on the bed, and bedside table and floor.Fda safety report id (b)(4).

• Brand Name: URINARY CATHETER
• Common Device Name: CATHETER, UROLOGICAL
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V.
• MDR Report Key: 15659213
• Report Number: MW5112805
• Device Sequence Number: 2749175
• Product Code: KOD
• UDI-Device Identifier: 00801741183218
• UDI-Public: (01)00801741183218
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: INTS14
• Device Catalogue Number: INTS14
• Device Lot Number: NGGU1639
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/21/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown