MAUDE Adverse Event Report: PRODUCTOS MEDLINE, S.A. DE C.V. MEDLINE INDUSTRIES, INC.; MICRO PUNCTURE 4FR REG

Model Number	DYNJMAST01
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported that the dilator broke off in the patient.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No sample was returned for evaluation.No additional information is available.Due to the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
The facility reported that the dilator broke off in the patient.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: MICRO PUNCTURE 4FR REG
• Manufacturer (Section D): PRODUCTOS MEDLINE, S.A. DE C.V.; blvd. world trade center no. 1; parque industrial oradel; nuevo laredo, tamaulipas 88285 ; MX 88285
• MDR Report Key: 10894897
• Report Number: 3004122598-2020-00009
• Device Sequence Number: 4001830
• Product Code: OEZ
• UDI-Device Identifier: 10888277538832
• UDI-Public: 10888277538832
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2020

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJMAST01
• Device Catalogue Number: DYNJMAST01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2020
• Initial Report FDA Received Date: 11/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other