MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 LUBRI-SIL TEMP-SENSING MOLEX; SENSING FOLEY CATHETER

Catalog Number 119216M

Device Problems Device Damaged by Another Device (2915); Material Protrusion/Extrusion (2979); Scratched Material (3020)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Inflammation (1932); Hematuria (2558)

Event Date 09/07/2015

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that after 7 days of insertion, a nurse noticed that a temperature sensing foley catheter wire was protruding out of 50% of the catheter.It was alleged that this caused a serrated edge.This resulted in a rough spot on the edge of the catheter which caused rubbing on the meatus of the penis.The patient experienced hematuria with large clots, bleeding, inflammation, and swelling at the entry point of the catheter.The foley catheter was removed immediately.The catheter was placed on (b)(6) 2015 and it was reported that the patient expired.The patient's reported death was an incidental element of the patient's medical history and is unrelated to the reason for the complaint.

Manufacturer Narrative

Received 1 used silicone temp-sensing foley catheter only.During the visual inspection it was noted that the thermistor wire was twisted or snaked inside of the thermistor lumen.The thermistor tip was out of its original position.The complaint has been confirmed with an unknown root cause.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: "special instructions: the position of the wire of the foley catheter with temperature sensor has an important effect on the amount of heating that may develop during an mri procedure.Accordingly, the foley catheter with temperature sensor must be positioned in a straight configuration down the center of the patient table (i.E., down the center of the mr system without any loop) to prevent possible excessive heating associated with an mri procedure.Visually inspect the product for any imperfections or surface deterioration prior to use.Do not stretch catheter.This will cause repositioning of probe.Do not use stylet.This will cause stretching of catheter." (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.

• Brand Name: LUBRI-SIL TEMP-SENSING MOLEX
• Type of Device: 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: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5197036
• MDR Text Key: 30513213
• Report Number: 1018233-2015-00433
• Device Sequence Number: 1
• Product Code: EZL
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2020
• Device Catalogue Number: 119216M
• Device Lot Number: NGZC3580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2015
• 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