MAUDE Adverse Event Report: MEDEGEN MEDICAL PRODUCTS GENT-L-KARE BULB IRRIGATION SYRINGE; SYRINGE, IRRIGATING (NON DENTAL)

Model Number 4090

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2021

Event Type  malfunction  

Event Description

Upon opening and introduction to the field, the entire tip of the syringe broke from syringe chamber.Fda safety report id # (b)(4).

• Brand Name: GENT-L-KARE BULB IRRIGATION SYRINGE
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): MEDEGEN MEDICAL PRODUCTS; gallaway TN 38036
• MDR Report Key: 12934654
• MDR Text Key: 281907134
• Report Number: MW5105815
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4090
• Device Catalogue Number: 4090
• Device Lot Number: 161612KS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic