MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD 2-WAY 5CC ALL-SILICONE FOLEY CATHETER

Catalog Number 165816

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Therapy/non-surgical treatment, additional (2519); Hematuria (2558); Alteration In Body Temperature (2682)

Event Type  Injury  

Event Description

It was reported that the patient experienced blood in his urine after catheter placement.The catheter was placed on (b)(4) 2014.The patient required bladder irrigation due to the blood in urine.Per additional information the pt was admitted for an abdominal aortic aneurysm repair.The foley was placed in the operation room.When the pt arrived in post op the hematuria was noted.The pt was taken for a cystoscopy and a new foley was placed during the procedure in order to perform bladder irrigation.It was during this time the patient was noted to have significant prostate enlargement.The foley remained in the patient after discharge and follow up care was required with the urologist.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.(b)(4).

• Brand Name: 2-WAY 5CC ALL-SILICONE FOLEY CATHETER
• Manufacturer (Section D): PRODUCTOS PARA EL CUIDADO DE LA SALUD; nogales, sonora ; MX
• Manufacturer (Section G): PRODUCTOS PARA EL CUIDADO DE LA SALUD; km. 7 carretera internacional; nogales, sonora 8562 1; MX 85621
• Manufacturer Contact: christy lewis ; 8195 industrial blvd.; covington, GA 30014 ; 7707846100
• MDR Report Key: 4339990
• MDR Text Key: 20361485
• Report Number: 1018233-2014-00345
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility,Company Representative
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 165816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2014
• Initial Date FDA Received: 12/12/2014
• 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
• Patient Age: 82 YR