MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARD LUBRI-SIL I.C. SILICONE 3-WAY FOLEY CATHETER, 30CC BALLOON, 18 FR.; BARDEX LUBRISIL

Catalog Number 73018SI

Device Problem Mushroomed (2987)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

Received 1 used half of a silicone catheter.Received the shaft with the catheter balloon.During the visual inspection, a cuff roll was observed.Per the dimensional evaluation, the active length was measured and the results were as follows: short side= 0.9145¿, long side=0.9235¿ (per specification, the active length is 0.9¿ to 1.0¿).Therefore, the catheter active length was found within specification.The reported event was confirmed with an unknown cause.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.

Event Description

It was reported that a #18 3 way silicone catheter allegedly got stuck in the patient's penis.It was unable to be remove after many attempts.The urologist had to be called in to remove the patient's catheter.Pain medication and anxiety medication had to be administered to the patient.The catheter was inserted in the emergency room and there was no documentation of lot or serial number.It was later found that the catheter had a cuff and as a result the catheter was unable to be removed.

• Brand Name: BARD LUBRI-SIL I.C. SILICONE 3-WAY FOLEY CATHETER, 30CC BALLOON, 18 FR.
• Type of Device: BARDEX LUBRISIL
• 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: 6385693
• MDR Text Key: 69323062
• Report Number: 1018233-2017-00906
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K070558
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 73018SI
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/14/2017
• 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
• Patient Outcome(s): Required Intervention