MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TRAY,CATHETER,SUCTION,8 FR,2 GLV,MINI

Catalog Number	DYND40988
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer on 2/8/2024," after several attempts to connect the device without success, they had to get another piece to connect the two.This caused a delay in the intubation of an infant that urgently needed it".The customer reported that the "staff had to go get a connecter piece from the stockroom to make the connection".The customer reported that there was no injury but that this "delayed" the procedure.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
According to the customer on 2/8/2024," after several attempts to connect the device without success, they had to get another piece to connect the two.This caused a delay in the intubation of an infant that urgently needed it".
Additional Manufacturer Narrative
Updated h6- type of investigation.

• Common Device Name: TRAY,CATHETER,SUCTION,8 FR,2 GLV,MINI
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 18861549
• Report Number: 1417592-2024-00342
• Device Sequence Number: 20903569
• Product Code: OFR
• UDI-Device Identifier: 40080196033523
• UDI-Public: 40080196033523
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 04/09/2024

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 Catalogue Number: DYND40988
• Device Lot Number: 6052305019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 02/08/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 04/09/2024
• 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