MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V.; SINGLE CAP CHANGE KIT W/MASK

Model Number	DYNDA2810
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a pre-filled nacl syringe was empty and that the component cracked.
Additional Manufacturer Narrative
It was reported that a pre-filled nacl syringe was empty and that the component cracked.No serious injury or adverse impact to a patient or to a user was originally reported.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.A sample was returned for evaluation and a crack in the barrel, from where the plunger enters to approximately half way to the syringe tip, was observed.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.

• Common Device Name: SINGLE CAP CHANGE KIT W/MASK
• Manufacturer (Section D): PRODUCTOS MEDLINE S.A. DE C.V.; blvd world trade center no.106; parque industrial oradel; nuevo laredo tamaulipas, 88285 ; MX 88285
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18927201
• Report Number: 3004122598-2024-00022
• Device Sequence Number: 19981342
• Product Code: LRO
• UDI-Device Identifier: 40193489881609
• UDI-Public: 40193489881609
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 03/17/2024

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: DYNDA2810
• Device Lot Number: 21DBI325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2024
• 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