MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX LUBRI-SIL ALL-SILICONE TEMP SENSING FOLEY CATHETER; TEMPERATURE SENSING FOLEY CATHETER

Model Number 119216M

Device Problem Material Split, Cut or Torn (4008)

Patient Problems Muscle Spasm(s) (1966); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 11/11/2020

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 there was a hole on the foley which caused leaking.Follow up via email on 19nov2020, the catheter was leaking urine and the patient was having bladder spasms around the foley and there had been multiple wet pads.The catheter was leaking where it connected to the tubing for the bag.Leaking pretty rapidly as the patient could able to see a drop of urine and wiped it away.The urine was back instantly and this was repeated a few times just to make sure it was leaking.

Manufacturer Narrative

The reported event was confirmed as manufacturing-related.Visual evaluation of the returned sample noted one opened (without original packaging), used temperature sensing silicone foley catheter.Visual inspection of the sample noted a pinhole measuring 0.017" found over the drainage lumen located 0.3875" from the trifurcation.This was out of specification per inspection procedure which states, "cuts in lumens are not allowed".A potential root cause for this failure mode could be ¿damage core pin or insert.Hit insert against the mold or the table.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.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.Patients with known allergy to silver coated catheter." 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.

Event Description

It was reported that there was a hole on the foley which caused leaking.Per follow up via email on 19nov2020, the catheter was leaking urine and the patient was having bladder spasms around the foley and there had been multiple wet pads.The catheter was leaking where it connected to the tubing for the bag.Leaking pretty rapidly as the patient could able to see a drop of urine and wiped it away.The urine was back instantly and this was repeated a few times just to make sure it was leaking.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10962906
• MDR Text Key: 220179306
• Report Number: 1018233-2020-21487
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741046308
• UDI-Public: (01)00801741046308
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• 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: 03/19/2021

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 Expiration Date: 11/30/2022
• Device Model Number: 119216M
• Device Catalogue Number: 119216M
• Device Lot Number: NGET2578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 04/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other