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

Model Number 0165L20

Device Problem Incorrect Measurement (1383)

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

Event Date 03/20/2021

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 the size of the 20mm foley catheter was more like size 18mm.Per follow up on (b)(6) 2021, stated that the patient had been buying foley catheters from april and using 20mm catheter and knew exactly how they feel.But patient recently bought 12 catheters and they did not feel the same and almost certain they were not 20mm but believed that those were more like 18mm.These products had not been used and did not wanted to use them because of smaller than 20mm they clogged up.Also confirmed the labeling looked correct.Patient was confirmed these products had not measured for the size or diameter.Per customer via phone on (b)(6) 2021, customer indicated the catheters were still not well.The 20f size felt more like a 18f size and they were too small.Also, customer ordered two additional catheters and they were also had same problem.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿program error¿.It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.Therefore, no additional action is required at this time.The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient" the device was not returned.

Event Description

It was reported that the size of the 20mm foley catheter was more like size 18mm.Per follow up on 18feb2021, stated that the patient had been buying foley catheters from april and using 20mm catheter and knew exactly how they feel.But patient recently bought 12 catheters and they did not feel the same and almost certain they were not 20mm but believed that those were more like 18mm.These products had not been used and did not wanted to use them because of smaller than 20mm they clogged up.Also confirmed the labeling looked correct.Patient confirmed these products had not measured for the size or diameter.Per customer via phone on 20mar2021, customer indicated the catheters were still not well.The 20f size felt more like a 18f size and they were too small.Also, customer ordered two additional catheters and they were also had same problem.

• 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
• MDR Report Key: 11657333
• MDR Text Key: 245386056
• Report Number: 1018233-2021-02088
• Device Sequence Number: 1
• Product Code: EZC
• UDI-Device Identifier: 00801741017506
• UDI-Public: (01)00801741017506
• 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: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0165L20
• Device Catalogue Number: 0165L20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other