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 02/17/2021

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 patient claimed, the size of the 20mm foley catheter was more like size 18mm.Per follow up it was stated that the patient had been buying foley catheters from apria and using 20mm catheter for a while so patient knew exactly how they feel.Also stated that patient recently bought 12 catheters and they did not feel the same.Patient was almost certain that they were not 20mm but believed that they were more like 18mm.These products had not been used and did not wanted to use them because patient stated that if used smaller than 20mm they clogged up.Also confirmed that labeling looked correct.Patient was confirmed these products had not measured for the size or diameter.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿program error¿.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "[warnings] 1.Method for use (1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injured.] 2.Applicable patients (1) patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1) do not use in patients who are or have been allergic to natural rubber latex." 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.The device was not returned.

Event Description

It was reported that the patient claimed, the size of the 20mm foley catheter was more like size 18mm.Per follow up it was stated that the patient had been buying foley catheters from april and using 20mm catheter for a while so patient knew exactly how they feel.Also stated that patient recently bought 12 catheters and they did not feel the same.Patient was almost certain that they were not 20mm but believed that they were more like 18mm.These products had not been used and did not wanted to use them because patient stated that if used smaller than 20mm they clogged up.Also confirmed that labeling looked correct.Patient was 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 feels more like a 18f size and they were too small.Also customer ordered two additional catheters which 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: 11474345
• MDR Text Key: 239682439
• Report Number: 1018233-2021-01229
• 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: 06/16/2021

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 Model Number: 0165L20
• Device Catalogue Number: 0165L20
• Device Lot Number: NGEX1193
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/12/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 07/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other