MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 LEG BAG

Catalog Number 150619

Device Problem Restricted Flow rate (1248)

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

Event Date 02/16/2024

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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.

Event Description

It was reported that the leg bag did not allow liquid to drain into the night bag.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.The potential root cause for this failure could be obstruction in tube, kinked tubing, wrong tubing dimensions".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: ¿bardiatm leg bag uriplantm leg bag description: the clinical benefits of leg bags are the ability to collect urine while allowing for a patient¿s mobility.Indications for use: leg bags are indicated for urine collection with urinary catheters as determined by a physician.Contraindication: no known contraindications.Precaution: keep leg bag below the bladder to ensure urine is flowing freely.Make sure all connections are compatible and fit securely.Ensure leg bag is secure to prevent slippage.A loose strap may cause leg bag to fall.Discard and replace bag if it becomes discolored, brittle or contains bad odor (even after cleaning).When leg bag is used with a foley catheter connection, it should remain in place for up to 7 days; dispose upon disconnection.When leg bag is used with a penile sheath/intermittent catheter, clean bag and disinfect as needed and replace every 7 days.Leg straps (if provided) are single use up to 7 days.Warnings: remove leg straps for conditions including, but not limited to: discoloration, swelling, numbness, rash, discomfort or if the leg strap is soiled.For pre-existing conditions, and/or if experiencing problems with use of the device, please consult your healthcare professional for assistance.Instructions for use: wash hands with soap and water, before and after handling the sheath/ catheter and/or leg bag.Placement 1.Thread straps through the top and bottom of the leg bag, as shown.2.Position the bag on the leg where it is most comfortable.Printing on the bag should be facing outwards.3.Secure the bag with leg straps.4.Ensure outlet valve is in the closed position.5.Remove cap from the inlet connector.6.Connect the urinary catheter to the inlet connector on the leg bag.If a needle-free sample port is present 1.Kink the drainage tubing approximately 5cm below the sampling port.2.Wipe the surface of the port with a sterile alcohol swab.3.Using an aseptic technique, position the syringe (luer slip tip only) in the center, perpendicular to the surface of the port, and then press the tip of the syringe into the sampling port.4.Aspirate the desired volume and then remove the syringe.5.Wipe the surface of the port with a sterile alcohol swab.6.Unkink the tubing and send the correctly labeled specimen to the laboratory.For lx codes only specifically, for penile sheath users, additional connectors have been included in the pack of uriplan¿/bardia¿ 750ml leg bags.The connectors will allow you to customize the tubing length and position the bag where it is most comfortable.1.Prior to first use, use clean scissors to cut tubing to the length required.2.Slightly push and twist the new connector into the tubing to secure in place.Emptying bag 1.Hold the bag over a toilet or container.2.To empty the bag, push the lever on the outlet valve out and down.3.Once bag is emptied, close outlet valve.4.Clean bag as needed and replace every 7 days.Disconnecting the bag 1.Ensure the bag is emptied.2.Pinch the urinary catheter to prevent urine from leaking.3.Disconnect the urinary catheter from the inlet connector with a twisting motion.4.Remove bag from the leg and dispose.5.See placement steps for attaching a new leg bag.Overnight link system 1.Do not disconnect your leg bag from the catheter.2.Connect a bed bag to the flexible tube at the bottom of the leg bag outlet.3.Once the two bags are securely connected, open the outlet of the leg bag to allow overnight drainage of urine into the bed bag.Cleaning and disinfection of leg bag when used with a penile sheath/ intermittent catheter system 1.Disconnect and remove leg bag.Ensure leg straps are removed from the leg bag before cleaning.2.Rinse: open the valve by pushing the lever down and drain the bag.With the valve open, rinse the bag with cool tap water.Remove any visible dirt by wiping leg bag with a disposable, low lint wipe.3.Cleaning: ensure valve is closed.A.With a funnel or bottle with a spigot, pour soap solution (5ml dish soap to 4l cool water) through the inlet tube and into the empty leg bag.Do not exceed the maximum volume mark in the bag.B.Shake solution inside the bag for 1 minute and then drain out of the leg bag.C.Fill bag a second time with soap solution and submerge bag in soap solution.Allow to sit for 10 minutes.While submerged, use a soft brush (e.G.Soft toothbrush) to brush off accessible areas for 1 minute to remove any visible debris or dirt.D.Drain soap solution from leg bag and rinse thoroughly with cool water until soap solution is no longer visible.E.Repeat if needed until debris and dirt is no longer visible.4.Disinfection: ensure valve is closed a.With a funnel or bottle with spigot, pour 70% isopropyl alcohol (ipa) through the inlet tube and into the empty leg bag.Do not exceed the maximum volume mark on the bag.B.Shake ipa inside the bag for 1 minute.Fully submerge leg bag in ipa and allow to sit for at least 15 minutes.C.Drain ipa out of leg bag.Contains or presence of phthalates: di(2-ethylhexyl) phthalate (dehp) is a plasticizer used in some polyvinyl chloride medical devices.Dehp has been shown to produce a range of adverse effects in experimental animals, notably liver toxicity and testicular atrophy.Although the toxic and carcinogenic effects of dehp have been well established in experimental animals, the ability of this compound to produce adverse effects in humans is controversial.There is no evidence that neonates, infants, pregnant and breast feeding women exposed to dehp experience any related adverse effects.However, a lack of evidence of causation between dehp-pvc and any disease or adverse effect does not mean that there are no risks.Users and/or patients within the european union, should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the member state in which the user and/or patient is established.Users outside of the european union should report any serious incident that has occurred in relation to the device to the manufacturer and the regulatory authority of the country in which the user and/or patient is established.¿ 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.

Event Description

It was reported that the leg bag did not allow liquid to drain into the night bag.Per follow up information received on 20feb2024, stated that no blockage could be seen.

• Brand Name: LEG BAG
• Type of Device: LEG BAG
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18846981
• MDR Text Key: 337011099
• Report Number: 1018233-2024-01166
• Device Sequence Number: 1
• Product Code: FAQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/08/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 150619
• Device Lot Number: NGHV4227
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• 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