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

Model Number 119316M

Device Problem Partial Blockage (1065)

Patient Problem Discomfort (2330)

Event Date 05/11/2021

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 had to replace now 5 foley catheter this past week due to the catheters clogging, hence it was unable to flush them.While removed the catheter, the end was completely clogged with sediment.For this reason customer skeptical that it was a product defect of any kind.Customer stated that it had happened 5 times within one week.Stated only 3 patients but it had happened twice on 2 different patients and look at the urine, none of them look overly sediment.Per followup on 24may2021, it was reported that the lot numbers of the temp foleys that were on the unit at the time of the issue was ngfn2849 and ngfq4012.Also stated that the patient had discomfort.In the case of one patient, they assumed decreased urine output was due to condition.In fact, once the bladder scanned, patient's bladder had over a liter of urine and had been proned for hours so they did not done it earlier.No medical intervention was reported.

Manufacturer Narrative

The reported event was confirmed cause unknown.One sample was confirmed to exhibit the reported failure.The device had not met specifications.The product was used for treatment.The product had caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), used foley catheter received with meter bag attached.Visual inspection of the sample noted noticeable amount of sediments in the catheter when detached from the meter.The catheter was injected with 10 ml methylene blue solution (3 drops 1 percentage aq methylene blue per 100ml distilled water) in the drainage lumen, and solution was prevented from draining out of the eyelets.A potential root cause for this failure mode could be ¿tooling misalignment".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: "bard® ez-lok® sampling port (indicated by the blue stem in the port) accepts luer lock or slip tip syringes 1.Occlude drainage tubing a minimum of 3 inches below the sampling port by kinking the tubing until urine is visible under the access site.2.Swab surface of bard® ez-lok® sampling port with antiseptic wipe.3.Using aseptic technique, position the syringe in the center of the sampling port.Press the syringe firmly and twist gently to access the sampling port.4.Slowly aspirate urine sample into syringe and remove syringe from sample port.5.Unkink tubing if necessary and transfer urine specimen into specimen cup or follow hospital protocol.Discard syringe according to hospital protocol.6.Follow established hospital protocol for specimen labeling and transport to lab.Sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Single use only.Do not resterilize.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the catheter and may cause balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Please consult product label and insert for any indications, contraindications, hazards, warnings, cautions and directions for use." the actual/suspected device was evaluated.

Event Description

It was reported that the patient had to replace now 5 foley catheter this past week due to the catheters clogging, hence it was unable to flush them.While removed the catheter, the end was completely clogged with sediment.For this reason customer skeptical that it was a product defect of any kind.Customer stated that it had had happened 5 times within one week.Stated only 3 patients but it had happened twice on 2 different patients and look at the urine, none of them look overly sediment.Per follow-up on 24may2021, it was reported that the lot numbers of the temp foleys that were on the unit at the time of the issue was ngfn2849 and ngfq4012.Also stated that the patient had discomfort.In the case of one patient, they assumed decreased urine output was due to condition.In fact, once the bladder scanned, patient's bladder had over a liter of urine and had been proned for hours so they did not done it earlier.No medical intervention was reported.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER
• Type of Device: TEMP SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11926505
• MDR Text Key: 253968227
• Report Number: 1018233-2021-03218
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741039911
• UDI-Public: (01)00801741039911
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

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: Health Professional
• Device Model Number: 119316M
• Device Catalogue Number: 119316M
• Device Lot Number: NGEN2543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 06/03/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 11/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other