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

Model Number 119314

Device Problems Inaccurate Flow Rate (1249); Fluid/Blood Leak (1250); Obstruction of Flow (2423)

Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)

Event Date 08/27/2020

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 urine was unable to be drain after the placement and leaked from somewhere.

Manufacturer Narrative

The reported event was unconfirmed.Visual inspection noted one temperature sensing catheter attached to a cut portion of inlet tubing was received without the original packaging.No obvious defects were noted.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and balloon concentricity was observed to be 50:50.This meets specification as concentricity should not exceed 70:30.The balloon rested for 30 minutes without leaks and passively deflated without issue or cuffing, returning 10ml of solution.Drainage lumen was flushed, and was able to drain as intended.No leaks were observed.This meets specifications as balloon fill being complete with no holes or tears.This meets specifications as no holes or damage being found on the shaft during testing.This meets specifications as no occlusions being found during testing.Although the reported event was unconfirmed, the most likely potential root cause for this failure could be tooling misalignment.The device history record review was not required as the reported event was unconfirmed.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.

Event Description

It was reported that urine was unable to be drain after the placement and leaked from somewhere.

• Brand Name: BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10593287
• MDR Text Key: 209216602
• Report Number: 1018233-2020-06226
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039843
• UDI-Public: (01)00801741039843
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 119314
• Device Catalogue Number: 119314
• Device Lot Number: NGDU1811
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Date Manufacturer Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1