MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 TOOMEY IRRIGATION SYRINGE

Catalog Number 0038460

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown, therefore the device history record could not be reviewed.The instructions for use states the following: "three syringe tips are intended for use as follows: integral toomey tip - resectoscope irrigation.Catheter tip - for catheter irrigation.One luer adapter (for foley catheter inflation).Warning: reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Caution: secure tip tightly prior to use.Caution: avoid excessive syringe pressure when using luer adapter, as the adapter may dislodge." (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.Device discarded.

Event Description

It was reported that the tip would not stay connected to the syringe when used for flushing a patient's ear.No medical intervention was required.No patient injury was reported.

• Brand Name: TOOMEY IRRIGATION SYRINGE
• Type of Device: TOOMEY IRRIGATION 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: 5294441
• MDR Text Key: 34014687
• Report Number: 1018233-2015-00553
• 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: other,user facility
• Reporter Occupation: Medical Assistant
• Type of Report: Initial
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0038460
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/19/2015
• 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