MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD FOLEY TRAY WITH BARDEX LUBRICATH FOLEY CATHETER

Catalog Number 899614

Device Problem Component Missing (2306)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

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 Description

It was reported that the jell was missing in the tray.

Event Description

It was reported that the jelly was missing from the tray.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential failure mode could be "missing components / accessories".A potential root cause for this failure could be due to "lack of training / incorrect training".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labeling 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: BARD FOLEY TRAY WITH BARDEX LUBRICATH FOLEY CATHETER
• Type of Device: FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10610183
• MDR Text Key: 209559593
• Report Number: 1018233-2020-06272
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/02/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 899614
• Device Lot Number: NGEQ2801
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/07/2020
• Initial Date FDA Received: 09/30/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1