MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline Industries, Inc.; TRAY,CON,EPID,19G REINF,W/TUOH

Model Number	PAIN1894
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer contact, "connector did not allow catheter to fully seat.Therefore it did not have proper flow and the catheter slipped out during the case.They tried to reinsert and it did not function properly".No injury was reported related to the incident.No additional information is available at this time.A sample has been requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Catheter slipped out during case.

• Brand Name: Medline Industries, Inc.
• Common Device Name: TRAY,CON,EPID,19G REINF,W/TUOH
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 17161969
• Report Number: 1417592-2023-00252
• Device Sequence Number: 20228265
• Product Code: OFT
• UDI-Device Identifier: 10195327283896
• UDI-Public: 10195327283896
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: PAIN1894
• Device Catalogue Number: PAIN1894
• Device Lot Number: 23BLB107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2023
• Initial Report FDA Received Date: 06/20/2023
• 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