MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SYRINGE,PISTON,IRRIGATION,60ML,STERILE

Model Number DYND20325

Device Problems Display Difficult to Read (1181); Leak/Splash (1354)

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

Event Date 09/11/2023

Event Type  malfunction  

Event Description

It was reported that the bulb irrigation syringe was leaking and that the markings were difficult to read.

Manufacturer Narrative

It was reported that the bulb irrigation syringe was leaking and that the markings were difficult to read.According to the reporting facility, "when inverted the fluid starts to flow out before the nurse exerts pressure on the plunger" and that the markings are clear instead of black.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.Samples were returned for evaluation and markings were confirmed to be difficult to read since they blend into the transparent background of the syringe barrel.The reported marking problem/issue is not a product defect.The reported leaking problem/issue was not confirmed.At the time of the incident, the reporting facility recently transitioned away from using bd bulb irrigation syringes and the root cause was determined to be customer preference.Due to the reported problem/issue, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.Additional lot numbers reported = 0332212a038, 033221a124, 96923010001.

• Type of Device: SYRINGE,PISTON,IRRIGATION,60ML,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18777200
• MDR Text Key: 337252168
• Report Number: 1417592-2024-00109
• 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: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYND20325
• Device Lot Number: 0332211A110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2023
• Date Manufacturer Received: 09/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other