MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URETERAL CATHETER ADAPTER

Catalog Number	140000
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when customer tried to open ureteral catheter, there was no product inside.
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.
Additional Manufacturer Narrative
The reported event was confirmed manufacturing related.Three photos were received for evaluation.The first one shows the back side of the product 140000 lot nggy5880, the second photo shows the other side evidencing the missing component.The last photo is a handwritten note in native language.Received 1 unopened ureteral catheter adapter packaging.Per visual inspection it was confirmed that there was no product inside, the packaging was empty.The returned sample does not meet specification which states: no missing or damaged components.No additional actions can be taken at this time.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 states the following: bard ureteral catheter adapter: this is a single use device.Do not resterilize any portion of this device.Reuse and or repackaging may create a risk of patient or user infection, compromise the structural integrity and or essential material and design characteristics of device, which may lead to device failure, and or lead to injury, illness or death of the patient.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state and federal laws and regulations.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 when customer tried to open ureteral catheter, there was no product inside.

• Brand Name: BARD® URETERAL CATHETER ADAPTER
• Common Device Name: URETERAL CATHETER ADAPTER
• 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: 20831375
• Report Number: 1018233-2024-07705
• Device Sequence Number: 8585034
• Product Code: KOD
• UDI-Device Identifier: 10801741130479
• UDI-Public: (01)10801741130479(11)221227(17)271031(10)NGGY5880
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2025

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 Catalogue Number: 140000
• Device Lot Number: NGGY5880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2024
• Supplement Date Received by Manufacturer: 02/08/2025
• Initial Report FDA Received Date: 12/03/2024
• Supplement Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2022
• 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