MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. 10-PACK RESERVOIR MMT-342 10PK EXTENDED; PUMP, INFUSION

Model Number MMT-342

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the customer observed a leak in the reservoir barrel.No harm requiring medical intervention was reported.Troubleshooting was performed, and the customer observed a leak at snap cap, spetum and o rings.It was unknown whether the customer would continue the use of the device.The reservoir will not be returned for analysis.

Manufacturer Narrative

This mdr related to the puerto rico manufacturing site has been assigned a medwatch number from the medtronic minimed northridge site, per variance 5.Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.No conclusion can be drawn at this time.We therefore consider this report complete to the best of our knowledge.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employees caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: 10-PACK RESERVOIR MMT-342 10PK EXTENDED
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386; * 00777-3869
• Manufacturer Contact: lusine boyadzhyan ; ceiba norte ind. park #50 road; juncos 00777--386 ; * 00777-3869
• MDR Report Key: 18948411
• MDR Text Key: 338193930
• Report Number: 2032227-2024-146038
• Device Sequence Number: 1
• Product Code: FRN
• UDI-Device Identifier: 002076300049718101
• UDI-Public: (01)002076300049718101(17)260508(10)HG72GZX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210714
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-342
• Device Catalogue Number: MMT-342
• Device Lot Number: HG72GZX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/07/2024
• Date Device Manufactured: 05/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 94 KG