MAUDE Adverse Event Report: CARDINAL HEALTH, INC. DOVER BULB SYRINGE,IRRIGATION WITH PROTECTIVE CAP; SYRINGE, IRRIGATING (NON DENTAL)

Model Number 67000

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/24/2022

Event Type  malfunction  

Event Description

The ball suction med-surg instrument used during surgery malfunctioning.The clear plastic part of the ball suction came off the ball and fell onto the patient's cord.

• Brand Name: DOVER BULB SYRINGE,IRRIGATION WITH PROTECTIVE CAP
• Type of Device: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 15851822
• MDR Text Key: 304209375
• Report Number: 15851822
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 67000
• Device Catalogue Number: 67000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/10/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1