MAUDE Adverse Event Report: NAMIC Medline Industries, Inc.; MICRO,PUNCTURE,4FR,REG,SS/SS

Model Number	DYNJMAST01
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/23/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, "item broke during patient use and was stuck inside patient." customer was able to remove the product using "on hand tools." due diligence has been completed.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.The sample has been requested to be returned for evaluation.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, "item broke during patient use and was stuck inside patient.".

• Brand Name: Medline Industries, Inc.
• Common Device Name: MICRO,PUNCTURE,4FR,REG,SS/SS
• Manufacturer (Section D): NAMIC; productos medline, s.a. de c.v; blvd. world trade center no. 1; nuevo laredo, tamaulipas 88285 ; MX 88285
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16787609
• Report Number: 3004122598-2023-00002
• Device Sequence Number: 14886287
• Product Code: OEZ
• UDI-Device Identifier: 10888277538832
• UDI-Public: 10888277538832
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/21/2023

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 Model Number: DYNJMAST01
• Device Catalogue Number: DYNJMAST01
• Device Lot Number: 22IBE163
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 04/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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