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

Catalog Number 165816

Device Problem Disconnection (1171)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

It was reported that the catheter disconnected from an unknown urinary drainage bag which lead to the patient's urinary tract infection.When the disconnect occurred, the patient reattached the catheter to the bag until her husband could get home to change the catheter and bag.Shortly after the disconnect occurred the patient developed a urinary tract infection and was taken to the emergency room.She was treated with iv antibiotics as well as ten days of oral antibiotics.

Manufacturer Narrative

The device was not returned for evaluation.The product was discarded.The reported issue is inconclusive.The device history record was reviewed and found no rejects.(b)(4).

• Brand Name: 2-WAY 5CC ALL-SILICONE FOLEY CATHETER
• Type of Device: EZL
• 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; 9611590; nogales, sonora 8562 1; MX 85621
• Manufacturer Contact: christy lewis ; 8195 industrial boulevard; covington, GA 30014 ; 7707846100
• MDR Report Key: 4360296
• MDR Text Key: 14879468
• Report Number: 1018233-2014-00355
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/25/2014

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: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 165816
• Device Lot Number: NGYF1851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2014
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN URINARY DRAIN BAG
• Patient Outcome(s): Required Intervention