MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; IRMO MINOR PACK

Model Number DYNJ39200B

Device Problem Connection Problem (2900)

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

Event Date 05/10/2019

Event Type  malfunction  

Event Description

It was reported that a bulb irrigation syringe component "falls apart.".

Manufacturer Narrative

It was reported that the bulb of the bulb irrigation syringe was separating from the barrel during use.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.A sample was returned for evaluation.Visual inspection found no observable defects.Functional testing was performed and the reported bulb separation was unable to be recreated.The reported problem/issue could not be confirmed and a root cause was unable to be determined.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.

• Type of Device: IRMO MINOR PACK
• 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: 18768772
• MDR Text Key: 336963633
• Report Number: 1423395-2024-00037
• Device Sequence Number: 1
• Product Code: FDE
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ39200B
• Device Lot Number: 19BBE255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Manufacturer Received: 05/10/2019
• Initial Date FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other