MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; EPIDURAL KIT/OR

Model Number	PAIN1910
Medical Device Problem Codes	Leak/Splash (1354); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the plunger of a loss-of resistance (lor) syringe component was "not sealed.".
Additional Manufacturer Narrative
It was reported that the plunger of an lor syringe component was "not sealed." reportedly the plunger did not hold pressure and leakage was experienced.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.The reporting facility returned three (3) used lor syringes for evaluation.The syringes were in good condition with no visible defects.Each syringe was tested using tap water as the solution.Resistance was applied at the hub of the syringes while the plunger was being depressed.It was observed that solution in the barrel was leaking past the barrel seal.The reported problem/issue was confirmed.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: EPIDURAL KIT/OR
• 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: 18833474
• Report Number: 1417592-2024-00145
• Device Sequence Number: 7140736
• Product Code: OFT
• UDI-Device Identifier: 40195327323234
• UDI-Public: 40195327323234
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2024

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: PAIN1910
• Device Lot Number: 23CBK201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2023
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown