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 Difficult to Remove (1528); Folded (2630)

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 cuff on it.As a result, the catheter was difficult to remove.

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 cuff on it.As a result, the catheter was difficult to remove.

Manufacturer Narrative

Received 1 piece of a used silicone catheter.Only the part of shaft and tip was returned.During the visual inspection, it was noted that the bifurcation channel was cut off upon return.The channel was not returned with the sample.However, no cuff roll was observed.The functional evaluation was unable to be performed due to poor sample conditions.Per the dimensional evaluation, the active length was measured and the results were as follows: short side= 0.8410¿, long side= 0.8685¿ (per specification, the active length is 0.6¿ to 0.9¿).Therefore, the catheter active length was found within specification.The reported issue was inconclusive due to the poor sample condition.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "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.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.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." (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 cuff on it.As a result, the catheter was difficult to remove.

• 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: 6282629
• MDR Text Key: 66229757
• Report Number: 1018233-2017-00219
• 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: distributor,other,user facili
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/18/2017

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 Catalogue Number: 175816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2017
• Initial Date FDA Received: 01/27/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/16/2017; 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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