MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 EAR/ULCER SYRINGE

Catalog Number 0005270

Device Problems Break (1069); Burst Container or Vessel (1074)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No sample was returned for evaluation.The lot number is unknown, therefore the device history record could not be reviewed.The instructions for use states the following: "cautions: sterile: sterile unless package is damaged or open.A 2 oz.With broad tip for aspiration and irrigation.Resterilization instructions: for product numbers 0005260, 0005270, 0005290 clean thoroughly before resterilizing.When sterilizing by ethylene oxide, follow instructions recommended by the manufacturer of the sterilization equipment or utilize cycles which have been validated by your facility (maximum 6 cycles).When sterilizing by steam autoclave, do not exceed cycles of 10 minutes at 270°f (maximum 6 cycles)." (b)(4).

Event Description

It was reported that upon opening the package, the syringe burst open.The complainant reported that she uses the syringes to suction fluid out of her son's nose.She reported that her son has special needs and cannot swallow any fluid, so the syringes are used to keep him alive.

• Brand Name: EAR/ULCER SYRINGE
• Type of Device: EAR/ULCER SYRINGE
• 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: 5617982
• MDR Text Key: 44715348
• Report Number: 1018233-2016-00533
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 0005270
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1