MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-FH BREAST TRAY PACK

Model Number DYNJ58264

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/13/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the bulb of the bulb irrigation syringe component is detaching when the bulb is squeezed.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.No physical damage was noted during visual inspection.Functional testing was performed and the component was found to hold water and no bulb detachment occurred during use.An identical bulb irrigation syringe from stock was pulled as well for testing.While the component does have a detachable bulb, nothing appeared to be out of specification.No defects were identified and the cause of the reported problem/issue was determined to be related to item preference at the reporting facility.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.

Event Description

It was reported that the bulb of the bulb irrigation syringe component is detaching.

• Type of Device: DBD-FH BREAST TRAY 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: 18803375
• MDR Text Key: 336507575
• Report Number: 1423395-2024-00078
• Device Sequence Number: 1
• Product Code: LRO
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ58264
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Date Manufacturer Received: 02/13/2020
• 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