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

Model Number	802015
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	01/21/2021
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.The device was not returned.
Event or Problem Description
It was reported that the (b)(6) 10 cc tray had no lubricant.Per follow-up on 08feb2021, the customer stated that the lubricant was missing from the bard insertion kit.
Event or Problem Description
It was reported that the bardia foley 10 cc tray had no lubricant.Per follow-up on 08feb2021, the customer stated that the lubricant was missing from the bard insertion kit.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It was 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 device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review was not performed because labelling could not have prevented the reported failure.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• Brand Name: BARDIA UNIVERSAL CATHETER INSERTION TRAY
• Common Device Name: CATHETER INSERTION KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11326666
• Report Number: 1018233-2021-00517
• Device Sequence Number: 16419415
• Product Code: KNX
• UDI-Device Identifier: 00801741051159
• UDI-Public: (01)00801741051159
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2021

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: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 802015
• Device Catalogue Number: 802015
• Device Lot Number: NGET3747
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/21/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 02/15/2021
• Supplement Report FDA Received Date: 06/07/2021
• 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