MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® FOLEY CATHETER INSERTION TRAY FOR 5CC BALLOON

Catalog Number	802011
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that they opened the foley catheter insertion tray, the gloves were unwrapped meaning they were not sterile and the syringe was completely empty.The customer would like a replacement as soon as possible since they only carry one and they cannot use that one.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 opened the foley catheter insertion tray, the gloves were unwrapped meaning they were not sterile and the syringe was completely empty.The customer would like a replacement as soon as possible since they only carry one and they cannot use that one.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned for evaluation.A potential root cause for this failure could be "incorrect operation ".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review is not required because labeling could not have prevented the reported issue.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 device was not returned.

• Brand Name: BARDIA® FOLEY CATHETER INSERTION TRAY FOR 5CC BALLOON
• Common Device Name: FOLEY CATHETER INSERTION 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: 19059534
• Report Number: 1018233-2024-01923
• Device Sequence Number: 17811588
• Product Code: KNX
• UDI-Device Identifier: 00801741018305
• UDI-Public: (01)00801741018305
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2024

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: Lay User/Patient
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 802011
• Device Lot Number: NGHN2911
• 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: 03/18/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 04/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2023
• 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