MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; DBD-LUMBAR SPINE PACK 515093-P

Model Number DYNJ49273J

Device Problem Leak/Splash (1354)

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

Event Date 03/28/2023

Event Type  malfunction  

Event Description

It was reported that asepto not holding fluid, leaking out of syringe, and seal not complete.

Manufacturer Narrative

It was reported that asepto not holding fluid.Leaking out of syringe.Seal not complete.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.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

• Type of Device: DBD-LUMBAR SPINE PACK 515093-P
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: jeffrey de torres ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 19080220
• MDR Text Key: 339990358
• Report Number: 1423395-2024-00246
• Device Sequence Number: 1
• Product Code: OJH
• UDI-Device Identifier: 40195327097340
• UDI-Public: 40195327097340
• 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: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ49273J
• Device Lot Number: UNK MXC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other