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

Catalog Number 175816

Device Problems Break (1069); Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 2 of the catheters from the patient's (b)(6) order had split after 3 weeks of use.The patient noted on two occasions that he had used sellotape as a temporary measure to stop the leaks.There was no fault with the valves of the catheter.Per additional information received via email on (b)(6) 2019 from ibc representative, the spilt was in the wall of the catheter and was round in shape.Per additional information received via messenger on (b)(6) 2019 from ibc representative, the sellotape was used as a temporary measure to stop the leaks from the hole/split that was found in the wall of the catheter.Urine leaked from the hole.

Event Description

It was reported that 2 of the catheters from the patient's august order had split after 3 weeks of use.The patient noted on two occasions that he had used sellotape as a temporary measure to stop the leaks.There was no fault with the valves of the catheter.Per additional information received via email on 25 october 2019 from ibc representative, the spilt was in the wall of the catheter and was round in shape.Per additional information received via messenger on 28 october 2019 from ibc representative, the sellotape was used as a temporary measure to stop the leaks from the hole/split that was found in the wall of the catheter.Urine leaked from the hole.

Manufacturer Narrative

The reported event could not be confirmed as no sample was returned for evaluation.A potential failure mode could be ¿shaft breaks¿ with a potential root cause of ¿high modulus latex tubing design or inadequate material selection¿.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.Units this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Use luer tip syringe to inflate with stated ml of sterile water.Or for pre-filled products, remove clip and squeeze reservoir to inflate with stated ml of sterile water.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fi ll the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient." 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 device was not returned.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: LUBRISIL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9315350
• MDR Text Key: 177802296
• Report Number: 1018233-2019-07267
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 175816
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1