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

Model Number 0165L20

Device Problem Dent in Material (2526)

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

Event Date 10/12/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that foley catheter was resisting when tried to flush and fluid came rushing back at patient.When removed the foley the patient's bladder was drained and attempted to flush the catheter after removal it appeared to be clogged internally.Also confirmed that the user used drainage funnel to flush and was inflating only 5cc sterile water.Explained bard foley catheters with 5cc balloons must be inflated with 10cc of sterile water.Per investigator notification on (b)(6) 2021, the catheter was found to have an asymmetric balloon during evaluation.

Event Description

It was reported that foley catheter was resisting when tried to flush and fluid came rushing back at patient.When removed the foley the patient's bladder was drained and attempted to flush the catheter after removal it appeared to be clogged internally.Also confirmed that the user used drainage funnel to flush and was inflating only 5cc sterile water.Explained bard foley catheters with 5cc balloons must be inflated with 10cc of sterile water.Per investigator notification on 12oct2021, the catheter was found to have an asymmetric balloon during evaluation.

Manufacturer Narrative

The reported event was confirmed manufacturing related.1 sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment purposes.A potential root cause for this failure could be "operator error.Dull cutting tools.".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation no additional action is required at this time.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required as the reported event is confirmed manufacturing related.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 actual/suspected device was inspected.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12746271
• MDR Text Key: 279910175
• Report Number: 1018233-2021-06916
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017506
• UDI-Public: (01)00801741017506
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

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
• Device Model Number: 0165L20
• Device Catalogue Number: 0165L20
• Device Lot Number: NGEV2422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/03/2021
• Supplement Dates Manufacturer Received: 04/21/2022
• Supplement Dates FDA Received: 04/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2020
• 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