MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER; BARDEX LUBRISIL FOLEY CATHETER

Catalog Number 175814

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem 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.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 catheter had a pinhole in the balloon.The foley was removed for inspection after it was leaking during a pet scan.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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 catheter had a pinhole in the balloon.The foley was removed for inspection after it was leaking during a pet scan.

Manufacturer Narrative

Received 1 used catheter with syringe and package labeling only.The visual inspection noted no obvious defects.Per the functional evaluation, the balloon was inflated with 10 cc of a mix of tap water and blue methylene using a syringe and no leakage on catheter balloon was found.Then, the catheter was left for 10 minutes and no leakage on the balloon was found.The reported event was unconfirmed, as the problem could not be reproduced.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: "recommended inflation capacities 3cc balloon: use 5ml sterile water, 5cc balloon: use 10ml sterile water, 30cc balloon: use 35ml sterile water.Do not exceed recommended capacities.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use." (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 catheter had a pinhole in the balloon.The foley was removed for inspection after it was leaking during a pet scan.The patient had the catheter inserted for imaging study.The radionuclide was injected and the patient complained of being wet.The catheter balloon was found deflated.After observation, it was found to have a small pin hole leak.A second catheter was inserted and the imaging study was completed.Post imaging, the patient was found laying in a puddle of urine.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: BARDEX LUBRISIL FOLEY CATHETER
• 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: 6538954
• MDR Text Key: 74413530
• Report Number: 1018233-2017-02239
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984084
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2017

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 Expiration Date: 04/05/2021
• Device Catalogue Number: 175814
• Device Lot Number: NGAQ3623
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/02/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 05/16/2017; 06/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2016
• 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