MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY; CATHETER, RETENTION TYPE, BALLOON

Model Number	A942214
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Urinary Retention (2119); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient had foley catheter placed during day shift due to increases in bleeding and inability to void post partum.Upon shift change, foley catheter was draining appropriately.When this rn returned in am , night shift rn, reported feeling patients uterus deviated to the right, checking urine output, noticed there was no output in the foley bag, assessed and adjusted the tubing.Night shift rn stated that urine then started to collect in foley bag and she was able to drain 1100ml out at that time.Upon am assessment, a couple of hours after night shift rn emptied foley, this rn noticed there was no urine output in the bag.This rn adjusted the tubing, no kinks or dependent loops noted, was able to get 600ml of urine to drain.Fundus firm and midline.This rn attempted to empty bladder fully before removing foley, per previously written order.Foley catheter set aside in red biohazard bag with patient label.

• Brand Name: SURESTEP¿ FOLEY TRAY SYSTEM BARD® LUBRI-SIL® FOLEY CATHETER TRAY
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 19310227
• Report Number: 19310227
• Device Sequence Number: 17893452
• Product Code: EZL
• UDI-Device Identifier: 00801741074103
• UDI-Public: (01)00801741074103
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/10/2024
• Report Date (Section F): 01/10/2024

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: A942214
• Device Catalogue Number: A942214
• Device Lot Number: NGHP1792
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 05/14/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 34 YR
• Patient Sex: Female
• Date Report Sent to FDA: 01/10/2024