MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 FOLEY TRAYS

Device Problems Component Missing (2306); Missing Information (4053)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/13/2023

Event Type  malfunction  

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 Description

It was reported that the customer had bard foley catheter which had balloons that were not deflating.Per follow up via email on (b)(6) 2023, it was reported that it was tossed because it was used on a patient.They had others with the same lot.They opened an additional clean one to try it out and discovered difficulty in the deflation.They had 2 with the same lot and same issue.A third was trialed and had difficulty as stated above.The patient was okay- the surgeon was able to eventually get it to deflate.Per additional information received via customer on (b)(6) 2023, it was reported that to provide ifu on the foley catheter and on the kit, it did not say whether or not to test the balloon.

Manufacturer Narrative

Upon further review, bd has determined that this event is not reportable.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.

Event Description

It was reported that the customer had bard foley catheter which had balloons that were not deflating.Per follow up via email on 21nov2023, it was reported that it was tossed because it was used on a patient.They had others with the same lot.They opened an additional clean one to try it out and discovered difficulty in the deflation.They had 2 with the same lot and same issue.A third was trialed and had difficulty as stated above.The patient was okay- the surgeon was able to eventually get it to deflate.Per additional information received via customer on 13dec2023, it was reported that to provide ifu on the foley catheter and on the kit, it did not say whether or not to test the balloon.

• Brand Name: FOLEY TRAYS
• Type of Device: FOLEY TRAYS
• 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: 18418909
• MDR Text Key: 331608086
• Report Number: 1018233-2023-09365
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other