MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SINGLE SHOT EPIDURAL TRAY

Model Number	PAIN1642
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a loss-of-resistance (lor) syringe component has "no resistance to slow the pressure.".
Additional Manufacturer Narrative
It was reported that an lor syringe component has "no resistance to slow the pressure." the reporting facility confirmed that the reported problem/issue caused no patient harm at the time of the incident and that a new tray was subsequently opened and used.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 and an unsealed pain1642 tray from the reported lot.The sample syringes were in good condition with no visible defects.There was a smooth and unobstructed movement with a simulated pull and push of the plungers.The sample syringes were filled with tap water and epidural needles were attached.The needles were then pushed into a foam pad while depressing the plungers of the syringes.The resistance was sensed immediately.The needles were slowly pushed through the entire pad with resistance.The resistance finally released as the needles pierced the opposite end of the pad.The reported problem/issue could not be reproduced or 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: SINGLE SHOT EPIDURAL TRAY
• 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: 18833468
• Report Number: 1417592-2024-00144
• Device Sequence Number: 12547915
• Product Code: OFT
• UDI-Device Identifier: 40193489330152
• UDI-Public: 40193489330152
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: PAIN1642
• Device Lot Number: 23FMF046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2023
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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