MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 CATHETER STABILIZATION DEVICE

Catalog Number	NG0120
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
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 the customer had as a backup, the notification of the warehouse area since 1 piece of the statlock was missing that corresponds to the invoice 9019864213 to please support us with the follow-up of the missing piece.The product was back labeled in the cedis at the cj level, but not at the piece level and 1 ea was missing, it was of quality.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr is not reportable.Submitting the investigation details as additional information.The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.A labeling review is not required because labeling could not have prevented the reported issue.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Correction: d,f,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.
Event or Problem Description
It was reported that the customer had as a backup, the notification of the warehouse area since 1 piece of the statlock was missing that corresponds to the invoice (b)(4) to please support us with the follow-up of the missing piece.The product was back labeled in the cedis at the cj level, but not at the piece level and 1 ea was missing, it was of quality.

• Brand Name: CATHETER STABILIZATION DEVICE
• Common Device Name: STABILIZATION DEVICE
• 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: 23016087
• Report Number: 1018233-2025-07768
• Device Sequence Number: 9546688
• Product Code: KMK
• UDI-Device Identifier: 10801741076173
• UDI-Public: (01)10801741076173(11)250422(17)280328(10)JUKR8500
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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 Catalogue Number: NG0120
• Device Lot Number: JUKR8500
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 09/10/2025
• Supplement Report FDA Received Date: 10/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/22/2025
• 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