MAUDE Adverse Event Report: PRODUCTOS MEDLINE S.A. DE C.V.; TRAY,LACERATION,SAFETY NEEDLES

Catalog Number	DYNJ03013
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, "last week the needle holder broke and a physician was stuck with a needle.The physician had to be seen in the emergency room for blood work and started treatment for anti-aids retroviral (triple therapy).The stick happened after the needle was used on the patient".A sample is not available for evaluation.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, 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, "last week the needle holder broke and a physician was stuck with a needle.The physician had to be seen in the er for blood work and started treatment for anti-aids retroviral (triple therapy).The stick happened after the needle was used on the patient".

• Common Device Name: TRAY,LACERATION,SAFETY NEEDLES
• 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: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 19248202
• Report Number: 3004122598-2024-00035
• Device Sequence Number: 15264936
• Product Code: MCY
• UDI-Device Identifier: 40080196973829
• UDI-Public: 40080196973829
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 05/06/2024

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: DYNJ03013
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/06/2024
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown