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

Catalog Number	INTS14
Medical Device Problem Codes	Component Missing (2306); Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2024
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 as requested 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 they were having manufacturing or supply issues with urinary catheter kits.The uts have stated they have found multiple kits not containing any lubrication.They questioned whether there was supply issue with lubrication.These kits were not marked with a sticker like other kits that notify the user there were no sterile gloves or peri wipes in the kit for example.It just makes it hard to catheterize when there were multiple products missing from kit.The lot number for the 14 french intermittent straight catheter kit not containing lubrication was ngjq0350.
Additional Manufacturer Narrative
Upon further review, bd has determined that this event is not reportable.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 they were having manufacturing or supply issues with urinary catheter kits.The uts have stated they have found multiple kits not containing any lubrication.They questioned whether there was supply issue with lubrication.These kits were not marked with a sticker like other kits that notify the user there were no sterile gloves or peri wipes in the kit for example.It just makes it hard to catheterize when there were multiple products missing from kit.The lot number for the 14 french intermittent straight catheter kit not containing lubrication was ngjq0350.Per additional information received via email on 04oct2024, this was the only lot number that was affected, unfortunately no staff member kept an affected kit and could not find a kit with this specific lot number in any of the units, so their hope was that all the affected lots were already used or no longer in stock.They have not received any more reports that any kits still were not containing lubrication, but they know they had multiple staff members say they had found multiple kits not containing lubrication.

• 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 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: 20056873
• Report Number: 1018233-2024-05114
• Device Sequence Number: 7784169
• Product Code: KOD
• UDI-Device Identifier: 00801741183218
• UDI-Public: (01)00801741183218(11)240416(17)250731(10)NGJQ0350
• Combination Product (Y/N): Y
• Initial Reporter State: MN
• 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
• Report Date (Section B): 10/18/2024

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: INTS14
• Device Lot Number: NGJQ0350
• 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: 08/05/2024
• Supplement Date Received by Manufacturer: 10/18/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 10/22/2024
• 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