MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA FOLEY CATHETER INSERTION TRAY; SOLUTION

Model Number	802110
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
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.
Event or Problem Description
It was reported that the foley insertion tray did not come with the syringe or solution.Patient stated nurse had to use two trays for each insertion.
Event or Problem Description
It was reported that the foley insertion tray did not come with the syringe or solution.Patient stated nurse had to use two trays for each insertion.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned.It is unknown whether the device had met relevant specifications.Based on no patient involvement the product does not appear to have been used.However, the product is intended to be used for treatment purpose.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be "incorrect clearance by machine maintenance".The dhr review could not be performed without a lot number.A labeling review was not performed because labelling could not have prevented the reported failure.H11: section a through f - the information provided by bard represents all of 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 bard.

• Brand Name: BARDIA FOLEY CATHETER INSERTION TRAY
• Common Device Name: SOLUTION
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11321362
• Report Number: 1018233-2021-00456
• Device Sequence Number: 11584101
• Product Code: OHR
• UDI-Device Identifier: 00801741018268
• UDI-Public: (01)00801741018268
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2021

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 Model Number: 802110
• Device Catalogue Number: 802110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 05/16/2021
• Initial Report FDA Received Date: 02/12/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other