MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER WITH HYDROGEL COATING, 16 FR.

Catalog Number 175816

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

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 was found outside of the patient with the balloon completely deflated.When the registered nurse examined the catheter, there was a hole found in the distal end that leaked the water out of the balloon.No patient injury was reported.

Manufacturer Narrative

Received 1 used catheter with the drainage bag still attached.The reported issue was confirmed as manufacturing related.Per visual inspection a cut to 0.5¿ from the bifurcation on the inflation lumen was found.The dimension was taken with a ruler id ms3522 with calibration date 9/7/2016 due date 9/30/2017.Per functional evaluation was injected water by inflation lumen and leakage was noted by the cut below the bifurcation area on the inflation lumen.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 5cc sterile water.5cc balloon: use 10cc sterile water.30cc balloon: use 35cc sterile water.Visually inspect the product for any imperfections or surface deterioration prior to use." 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 was found outside of the patient with the balloon completely deflated.When the registered nurse examined the catheter, there was a hole found in the distal end that leaked the water out of the balloon.No patient injury was reported.

• Brand Name: BARDEX LUBRI-SIL ALL-SILICONE FOLEY CATHETER WITH HYDROGEL COATING, 16 FR.
• Type of Device: 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: 6500821
• MDR Text Key: 73233448
• Report Number: 1018233-2017-01842
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/27/2017

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: 10/27/2021
• Device Catalogue Number: 175816
• Device Lot Number: NGAX2491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2017
• Initial Date FDA Received: 04/18/2017
• Supplement Dates Manufacturer Received: 07/24/2017
• Supplement Dates FDA Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/28/2016
• 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