MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX LUBRI-SIL I. C. 2 WAY ALL-SILICONE FOLEY CATHETER WITH 5CC BALLOON

Catalog Number 1758SI16

Device Problem Mushroomed (2987)

Patient Problem Pain (1994)

Event Date 04/28/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.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 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." (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.The device was not returned.

Event Description

It was reported that upon removing the foley catheter, it allegedly became stuck in the patient's penis.Upon extraction, the nurse deflated the balloon and pulled the catheter 90% of the way out before meeting resistance at the end.Half of the balloon was visible and was noted to be deflated.The attending physician removed the catheter with no noted harm to the patient.The patient did allegedly complain of pain.The catheter appeared to be folded over on itself.The facility stated that it is unknown how the doctor removed the catheter.

• Brand Name: BARDEX LUBRI-SIL I. C. 2 WAY ALL-SILICONE FOLEY CATHETER WITH 5CC BALLOON
• 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: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5914128
• MDR Text Key: 54267707
• Report Number: 1018233-2016-01159
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984136
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/08/2016

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: Health Professional
• Device Catalogue Number: 1758SI16
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/08/2016
• Initial Date FDA Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention