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

Catalog Number	INTP14
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
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 customer had discovered 10 plus surestep intermittent catheter trays to be non-sterile.User was unable to use the product.
Event or Problem Description
It was reported that customer had discovered 10 plus surestep intermittent catheter trays to be non-sterile.User was unable to use the product.
Additional Manufacturer Narrative
The reported event is confirmed - cause unknown.Visual: received 6 opened and 8 unopened sure step intermittent catheter trays.Verified material number intp14 and batch number ngkr0336.Visual inspection noted six (6) trays noted were opened, three (3) of those trays had the most outer packaging opened (the white layer was not glued to the clear layer) and the three (3) other trays had no outermost packaging at all.Visual inspection noted eight (8) trays were unopened.Packaging showed no signs of damage.Sterility was not compromised.Instructions for use were reviewed for this investigation.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections: d, h 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.

• 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: 22554922
• Report Number: 1018233-2025-05993
• Device Sequence Number: 13151411
• Product Code: KOD
• UDI-Device Identifier: 00801741183294
• UDI-Public: (01)00801741183294(11)250509(17)270731(10)NGKR0336
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 01/29/2026

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: INTP14
• Device Lot Number: NGKR0336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Supplement Date Received by Manufacturer: 01/29/2026
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2025
• 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