MAUDE Adverse Event Report: C.R. Bard Inc. (Covington) -1018233 SureStep Intermittent Catheter Tray

Catalog Number	INTS16C
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a straight in and out catheterization procedure, the coude catheter tubing became disconnected from the collection bag.The device was reported to be intact prior to insertion.Urine initially drained into the collection bag, however, while the user was holding the coude tubing, the tubing separated from the bag and urine drainage stopped.Approximately 300 ml of urine had collected in the bag at the time of disconnection.A subsequent bladder scan indicated greater than 600 ml of urine remained in the patient's bladder.Photographs of the damaged tubing were reportedly taken.No patient injury was reported.
Additional Manufacturer Narrative
This report was impacted by emdr scheduled maintenance occurring july 22-27, 2026.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.

• Brand Name: SureStep Intermittent Catheter Tray
• Common Device Name: 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 ; +1(770)784-6100
• MDR Report Key: 50131780
• Report Number: 1018233-2026-04917
• Device Sequence Number: 10596663
• Product Code: KOD
• UDI-Device Identifier: 00801741183249
• UDI-Public: (01)00801741183249
• Combination Product (Y/N): Y
• Initial Reporter State: KY
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/16/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: INTS16C
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2026
• Supplement Date Received by Manufacturer: 09/16/2026
• Initial Report FDA Received Date: 08/04/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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