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

Catalog Number	INTL15
Medical Device Problem Code	Restricted Flow rate (1248)
Health Effect - Clinical Codes	Discomfort (2330); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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: section 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 new straight catheter leg bag to drain was collapsed on itself, so it did not drain.Customer had a patient that it took 45 minutes for the urine to fully drain.Nurses have said the bags were so compressed they did not allow urine to flow into the bag.Correct bag would not open and allow urine to drain, it took 45 mins to drain 700ml.Nurse did not utilize another kit.Did cause patient discomfort.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: indications for use: pvc & red rubber: for urological use only.Silicone: intended for use for bladder.Management including urine drainage, collection and measurement.The devices are generally passed to the urinary bladder via the urethra.Bard ez-lok sampling port (indicated by the blue stem in the port) accepts luer lock (fig.1a) or slip tip collection devices (fig.1b).Bd vacutainer urine products can be used for collection, storage, and transport of urine specimens from a urinary catheter.1.Swab surface of bard ez-lok sampling port with antiseptic (fig.2) e.G., site-scrub ipa device which is an effective disinfecting agent for luer hubs.2.Using aseptic technique, position the collection device in the center of the sampling port.Press the device firmly and twist gently to access the sampling port.(fig.3).3.If using bd vacutainer luer-lok access device (fig.4), collect urine into the bd vacutainer tubes per hospital protocol.If using syringe, slowly aspirate urine sample into syringe and transfer to collection cup or follow hospital protocol.4.After sample is obtained, discard collection device according to hospital protocol.5.Follow established hospital protocol for specimen labeling and transport to lab.Single use only.Do not resterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter.Udi format updated with available product information per gudid.H11: section 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 new straight catheter leg bag to drain was collapsed on itself, so it did not drain.Customer had a patient that it took 45 minutes for the urine to fully drain.Nurses have said the bags were so compressed they did not allow urine to flow into the bag.Correct bag would not open and allow urine to drain, it took 45 mins to drain 700ml.Nurse did not utilize another kit.Did cause patient discomfort.No medical intervention was reported.Per follow up response received via email on 04dec2024, this was a complaint from this summer.Since then, they had catheter bard education.They would say that nursing staff have still found this a challenge, but a few education techniques have helped.

• 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 30014 ; 7707846100
• MDR Report Key: 20371454
• Report Number: 1018233-2024-06245
• Device Sequence Number: 12458239
• Product Code: KOD
• UDI-Device Identifier: 00801741183171
• UDI-Public: (01)00801741183171(11)240307(17)250731(10)NGJP0945
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 01/07/2025

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 Expiration Date: 07/31/2025
• Device Catalogue Number: INTL15
• Device Lot Number: NGJP0945
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/07/2024
• 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