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

Model Number 01267520

Device Problems Fluid/Blood Leak (1250); Decrease in Pressure (1490)

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

Event Date 01/21/2021

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 during a pretest, the water leaked from a damage of the balloon.

Event Description

It was reported that during a pretest, the water leaked from a damage of the balloon.

Manufacturer Narrative

The reported event was confirmed as manufacturing related.One sample was confirmed to exhibit the reported failure.An amber 3 way foley catheter was returned opened with original packaging.The catheter was attempted to be inflated with 80 ccs of di water using a luer lock syringe.Water began to spray from the drainage eye.Lumen to lumen leakage is the cause of the reported failure.Sample does not meet specification, as it would fail functional leak testing.A potential root cause for this failure could be "operator error".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not required as the reported event is confirmed as manufacturing related.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 actual/suspected device was inspected.

• Brand Name: BARDEX LUBRICATH FOLEY CATHETER CREEVY MODEL
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11333832
• MDR Text Key: 232053063
• Report Number: 1018233-2021-00547
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741018800
• UDI-Public: (01)00801741018800
• Combination Product (y/n): N
• PMA/PMN Number: K910195
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 10/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 01267520
• Device Catalogue Number: 01267520
• Device Lot Number: NGET3647
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Date Manufacturer Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other