MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 CHANNEL DRAIN, 10FR., HUBLESS FULL FLUTE WITH TROCAR; SILICONE CHANNEL DRAIN

Model Number 072227

Device Problem Material Fragmentation (1261)

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

Event Date 05/25/2022

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 drain part came off from the trocar during use.It seemed that there was no tension and user did not apply any extra force to the disconnected part.Per follow-up information received on 10oct2022, the drain part seemed to be broken.

Event Description

It was reported that drain part came off from the trocar during use.It seemed that there was no tension and user did not apply any extra force to the disconnected part.Per follow-up information received on 10oct2022, the drain part seemed to be broken.

Manufacturer Narrative

The reported event was confirmed cause unknown.1sample were confirmed to exhibit the reported failure.The device had not met specifications.The product was used for patient treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), channel drain with a trocar and packaging.Visual inspection of the sample noted the round channel silicone drain broken from the trocar.This does not meet specification which states " no cuts or tears are allowed on the surface of the drains".A potential root cause for this event could be ¿efd without calibration.Efd out of parameters.Incorrect assembly.Components out of spec".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 (fig.1a) or slip tip syringes (fig.1b).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.(fig.2) 3.Using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80 - 100 degree angle).Press the syringe firmly and twist gently to access the sampling port.(fig.3) 4.Slowly aspirate urine sample into syringe and remove syringe from sample port.(fig.4) 5.Unkink tubing 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 re-sterilize.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.Proper techniques for urinary catheter insertion perform hand hygiene immediately before and after insertion insert urinary catheters using aseptic technique and sterile equipment use the smallest foley catheter possible, consistent with good drainage document the indications for catheter insertion, date and time of catheter insertion, individual who inserted catheter, and date and time of catheter removal in the patient record.Proper techniques for urinary catheter maintenance secure the foley catheter.Use the statlock® foley stabilization device if provided maintain a closed drainage system by utilizing pre-connected, sealed catheter-tubing junctions maintain unobstructed urine flow and keep the catheter and collection tube free from kinking keep the collection bag below the level of the bladder or hips at all times empty the collection bag regularly using a separate, clean collection container for each patient.Directions for use.1.Wash hands and don clean gloves 4.Use the provided cleansing wipe to cleanse patient¿s peri-urethral area 2.Using proper aseptic technique open outer csr wrap 5.Remove gloves and perform hand hygiene with provided alcohol hand sanitizer gel 3.Place underpaid beneath patient, plastic/¿shiny¿ side down 6.Don sterile gloves 7.Position fenestrated drape on patient 8.Remove top tray and place next to bottom tray (keep on csr wrap) 10.Remove foley catheter from wrap and lubricate catheter 12.Proceed with catheterization in usual manner.When catheter tip has entered bladder, urine will be visible in the drainage tube.Insert catheter two more inches and inflate catheter balloon improperly inflated with less than the recommended volume of sterile water 14.Once inflated, gently pull catheter until the inflated balloon is snug against the bladder neck 15.Secure the foley catheter to the patient use the statlock ® foley stabilization device if provided (see statlock ® foley stabilization device ifu) note: please make sure patient is appropriate for use of statlock® stabilization device.16.Position hanger on bed rail at the foot of the bed note: exercise care to keep bag off the floor 17.Use green sheeting clip to secure drainage tube to the sheet.Make sure tube is not kinked 18.Indicate time and date of catheter insertion on provided labels.Place designated labels on patient chart and drainage system 19.Document procedure according to hospital protocol 13.Inflate catheter balloon using sterile water and fill with recommended volume as referenced on product label.11.Prepare patient with packet of presaturated antiseptic swab sticks note: use each swab stick for one swipe only female patient: with a downward stroke cleanse the right labia minora and discard the swab.Do the same for the left labia minora.With the last swabstick cleanse the middle area between the labia minora male patient: cleanse the penis in a circular motion starting at the urethral meatus and working outward note: it is not necessary to pre-test the foley catheter balloon foley catheter removal 1.To deflate catheter balloon: gently insert a luer lock or slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve 2.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently 3.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation 4.If the balloon will not deflate and if permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol 5.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient 9.Attach the water filled syringe to the inflation port." 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.H3 other text : the actual/suspected device was inspected.

• Brand Name: CHANNEL DRAIN, 10FR., HUBLESS FULL FLUTE WITH TROCAR
• Type of Device: SILICONE CHANNEL DRAIN
• 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: 15587211
• MDR Text Key: 306595754
• Report Number: 1018233-2022-07778
• Device Sequence Number: 1
• Product Code: GBX
• UDI-Device Identifier: 00801741049873
• UDI-Public: (01)00801741049873
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 072227
• Device Catalogue Number: 072227
• Device Lot Number: NGFU2417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• 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