MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 LUBRI-SIL AQUAFIL, HYDROGEL COATED ALL SILICONE FOLEY CATHETER, MALE LENGTH; LUBRISIL

Catalog Number D175812E

Device Problem Deflation Problem (1149)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "directions for use 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.Open outer white wrapping to prepare sterile field and place under pad beneath patient, plastic side down.If patient has a catheter in-situ 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 fill the syringe with water.If you notice slow or no deflation, reseat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.Wait at least 30 seconds for deflation.If permitted by local protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance as directed by local protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Put on gloves, cover patient with fenestrated drape with open exposing location where catheter will be inserted, and place the apron on yourself.Using the two (2) syringes, marked ¿for cleansing purposes only¿, dispense the water onto three (3) gauze squares.Prepare the patient by wiping down the catheter insertion site with the saturated gauze squares.Dry patient with the remaining two (2) gauze squares.Note: do not use this syringe to inflate the catheter balloon.Prepare the lubricating gel syringe by removing the cap from the syringe tip.For easing with the insertion of the catheter into the patient dispense the lubricating gel into the urethra (according to local protocol).Remove top tray and open plastic pouch (sleeve) surrounding the catheter.Proceed with catheterization according to local protocol.To inflate catheter, simply insert tip of sterile water-filled syringe gently into valve (do not over penetrate) and depress plunger.Instill entire amount of sterile water - 10 ml." (b)(4) the information provided by bard 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 bard.

Event Description

It was reported that the device allegedly fell out of the patient, at which time a hole was identified in the catheter balloon.The patient was awaiting a turp operation.He underwent a bladder scan, and no stones or signs of spasms were noted.Since (b)(6) 2016, the patient has experienced frequent uti's, and it was confirmed that the catheter balloon did not contribute to the alleged uti's.The catheter was placed in the urethra, and initiated due to the patient going into heart failure and full retention.

• Brand Name: LUBRI-SIL AQUAFIL, HYDROGEL COATED ALL SILICONE FOLEY CATHETER, MALE LENGTH
• Type of Device: LUBRISIL
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590; km. 7 carretera internacional; nogales, sonora 85621 ; MX 85621
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6211867
• MDR Text Key: 63762900
• Report Number: 1018233-2016-01888
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/05/2016

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: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: D175812E
• Device Lot Number: NGAQ3391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2016
• 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