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

Catalog Number 0038460

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the tip fell off the syringe.The only patient impact was a slight delay in the procedure when they were trying to irrigate a foley catheter and it wouldn't stay connected.

Manufacturer Narrative

(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 to any further patient, product, or procedural details to bard.

• Brand Name: TOOMEY IRRIGATION SYRINGE
• 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: 4894364
• MDR Text Key: 6535747
• Report Number: 1018233-2015-00210
• 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,Company Representative
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2015
• 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: 06/08/2015
• 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