MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V.; DBD-ASED 40

Model Number	DYNDV2384A
Medical Device Problem Codes	Contamination (1120); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that kits received included cracked syringes and syringes with "black debris" inside.
Additional Manufacturer Narrative
It was reported that kits received included cracked syringes and syringes with "black debris" inside.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.No photos were provided and no samples were received for evaluation.A root cause was unable to be determined.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.Additional lot numbers reported = 20jbm051, 20lbo236.

• Common Device Name: DBD-ASED 40
• 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: 18826481
• Report Number: 3004122598-2024-00005
• Device Sequence Number: 3047686
• Product Code: LRO
• UDI-Device Identifier: 40193489309844
• UDI-Public: 40193489309844
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 03/03/2024

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: DYNDV2384A
• Device Lot Number: DBD-ASED 40
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown