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

Catalog Number	DYNJ03013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 the forceps broke off inside the patient during "normal use" and the piece was "easily retrieved".The customer reported the patient is "stable" and there was no serious injury, medical intervention, or follow up care related to the reported incident.No additional information is available.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, 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, on (b)(6) 2024 the forceps broke off inside the patient during "normal use" and the piece was "easily retrieved".

• 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: danielle tognocchi ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19326060
• Report Number: 3004122598-2024-00036
• Device Sequence Number: 2569755
• 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): 05/15/2024

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
• Operator of Device: Health Professional
• 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: 05/15/2024
• 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