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

Model Number	INTS14
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2023
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.
Event or Problem Description
It was reported that nurse attempted to straight catheter a patient on (b)(6) 2023, the catheter did not have any openings at the end of the tube for fluid to flow.
Event or Problem Description
It was reported that nurse attempted to straight catheter a patient on (b)(6) 2023, the catheter did not have any openings at the end of the tube for fluid to flow.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.Visual evaluation noted received 1 surestep intermittent catheter with no eyelets present.Therefore, product does not meet specifications which states "missing components are not allowed." although an exact root cause could not be determined a potential root cause could be: thermocouple ooc: - thermocouple failure.Electrical failure.- inconsistent temp/hum profile.Dhr review did not show any problems or conditions that would have contributed to the reported event.Labelling review is not required as the reported event is confirmed manufacturing related.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.H3 other text : the actual/suspected device was inspected.

• Brand Name: SURESTEP INTERMITTENT CATHETER TRAY
• Common Device Name: CATHETER TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16761547
• Report Number: 1018233-2023-02639
• Device Sequence Number: 17687537
• Product Code: KOD
• UDI-Device Identifier: 00801741183218
• UDI-Public: (01)00801741183218
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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: 03/31/2025
• Device Model Number: INTS14
• Device Catalogue Number: INTS14
• Device Lot Number: NGGY1090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Supplement Date Received by Manufacturer: 09/05/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2022
• 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