MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DELIVERY PACK-LF

Catalog Number	DYNJ0378527Q
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported on (b)(6) 2024 when attempting to suction the ears and nose of a "newborn" the suction was not working due to the bulb being "separated".The customer reported they replaced the device and completed the task.The customer reported the patient is "completely fine".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 1417592 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.
Event or Problem Description
It was reported on (b)(6) 2024 when attempting to suction the ears and nose of a "newborn" the suction was not working due to the bulb being "separated".
Additional Manufacturer Narrative
Update to d9: returned to manufacturer.Update to h3: device evaluated by manufacturer.Update to h6: type of investigation.

• Common Device Name: DELIVERY PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19650576
• Report Number: 1423395-2024-00440
• Device Sequence Number: 6586893
• Product Code: MLS
• UDI-Device Identifier: 40193489219303
• UDI-Public: 40193489219303
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 07/01/2024

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ0378527Q
• Device Lot Number: 24ABO889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 07/02/2024
• 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
• Patient Sex: Unknown