MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 SURESTEP INTERMITTENT CATHETER TRAY

Catalog Number	53314
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complete initial reporter's facility name is (b)(6).The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Udi format updated with available product information per gudid.H11: sections a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the intermittent catheter had very poor drainage.Registered nurse had to manipulate the catheter to encourage urine to drain.This had been a repeated event according to the rn mngr of this l&d unit.Urine remains stagnant in catheter and does not flow smoothly.
Event or Problem Description
It was reported that the intermittent catheter had very poor drainage.Registered nurse had to manipulate the catheter to encourage urine to drain.This had been a repeated event according to the rn mngr of this l&d unit.Urine remains stagnant in catheter and does not flow smoothly.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Correction: d.Udi format updated with available product information per gudid.H11: sections a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings, and no sample was available for evaluation.The reported event is addressed within the labeling as it state: warnings: this is a single use device.Do not reuse.Reuse of a single use device increases the risk of catheter acquired urinary tract infections.How to prepare and use your urinary catheter: wash your hands thoroughly with soap and water.Peel open the pack at the funnel end to expose approximately 2¿- 4¿ of the catheter.Don't remove the catheter yet.Wash the area around the meatus before catheterizing.Wash your hands again.Using the catheter: # with sure-grip sleeve: hold the sure-grip sleeve with your dominant hand and squeeze it to hold the catheter shaft as you remove the catheter from the pack.Next, hold the catheter funnel above the sure-grip sleeve with your other hand and slide the sure-grip sleeve down the shaft, stopping at about 6¿ from the tip.Release the funnel.Using the sure-grip sleeve to hold the catheter firmly, lubricate catheter tip with lubricating gel.While gripping the catheter with the sure-grip sleeve, gently pass the tip of the catheter into your urethra until the sure-grip sleeve nears the meatus.If there is no urine flow, loosen the tension on the sure-grip sleeve to allow it to slide back towards the funnel end.Re-grip sure-grip sleeve and continue to insert the catheter into the urethra.Repeat until urine starts to flow.# without sure-grip sleeve: remove the catheter from the pack.Lubricate the catheter tip with lubricating gel.Gently pass the tip of the catheter into your urethra and advance the catheter until urine starts to flow.Try to keep the catheter steady until urine stops flowing.When urine stops flowing, slowly withdraw the catheter, stopping if flow starts again, until the last few drops have drained.Finish by disposing of the catheter and its packaging.Wash your hands with soap and water.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Udi format updated with available product information per gudid.H11: sections a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the intermittent catheter had very poor drainage.Registered nurse had to manipulate the catheter to encourage urine to drain.This had been a repeated event according to the rn mngr of this l&d unit.Urine remains stagnant in catheter and does not flow smoothly.

• Brand Name: SURESTEP INTERMITTENT CATHETER TRAY
• Common Device Name: INTERMITTENT CATHETER TRAY
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23191351
• Report Number: 1018233-2025-08743
• Device Sequence Number: 9108958
• Product Code: KOD
• UDI-Device Identifier: 00801741183218
• UDI-Public: (01)00801741183218
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/25/2025

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 Catalogue Number: 53314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2025
• Supplement Date Received by Manufacturer: 10/27/2025; 11/25/2025
• Initial Report FDA Received Date: 10/01/2025
• Supplement Report FDA Received Date: 11/11/2025; 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown