MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SYRINGE,EAR/ULCER, 3 OZ, STERILE

Catalog Number	DYND70277
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, "our l&d staff reported that one of them has bad suction and they had to change it during a resuscitation due to it not suctioning".There was no further details.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
According to the facility, "our l&d staff reported that one of them has bad suction and they had to change it during a resuscitation due to it not suctioning".

• Common Device Name: SYRINGE,EAR/ULCER, 3 OZ, STERILE
• 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: 20351346
• Report Number: 1417592-2024-00874
• Device Sequence Number: 7931552
• Product Code: KYZ
• UDI-Device Identifier: 40080196862543
• UDI-Public: 40080196862543
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2024

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 Catalogue Number: DYND70277
• Device Lot Number: 96924030001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 10/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown