MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 5CC LUBRI-SIL TEMP-SENSING (MOLEX) ALL SILICONE FOLEY CATHETER, 16 FR.; LUBRISIL TEMPERATURE SENSING FOLEY CATHETER

Catalog Number 119216M

Device Problems Difficult to Remove (1528); Mushroomed (2987)

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 device had a ridge on the body of the catheter, allegedly making it difficult to remove.

Manufacturer Narrative

The reported issue (it was reported that the device had a ridge on the body of the catheter, making it difficult to remove) was confirmed.The device was returned, and per visual evaluation a cuff roll was observed on a portion of the catheter.No defects were observed.Performing a functional evaluation was not possible due to only a portion of the catheter was returned for evaluation.However, a dimensional evaluation found that the catheter was within specification.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "to deflate catheter balloon: gently insert a 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.Visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities: 5 cc balloon: use 10 cc sterile water." 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 had a ridge on the body of the catheter, allegedly making it difficult to remove.

• Brand Name: 5CC LUBRI-SIL TEMP-SENSING (MOLEX) ALL SILICONE FOLEY CATHETER, 16 FR.
• Type of Device: LUBRISIL TEMPERATURE SENSING 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: 6532251
• MDR Text Key: 74176619
• Report Number: 1018233-2017-02132
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 119216M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/24/2017
• 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