MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 3ML MMT-332A; PUMP, INFUSION

Model Number	MMT-332A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.
Event or Problem Description
Information received by medtronic indicated that reservoir had leak on past second o ring.Customer stated seal at the bottom of reservoir came out.No harm requiring medical intervention was reported.The reservoir will be returned for analysis.
Additional Manufacturer Narrative
Evaluated 1 open/used reservoir.Inspected reservoir's o-rings or stopper groove for anomalies.None were found.Ran basal, bolus leaking test per dop114-811 as follows: using a new transfer guard and plunger reservoir filled with diluent and connected to a new infusion set.Installed reservoir and connector into a paradigm pump.Conclusion: reservoir does not have air bubbles and does leak.(b)(4).
Additional Manufacturer Narrative
Evaluated 1 open or used reservoir (transfer guard and plunger not returned).Inspected reservoir's o-rings or stopper groove for anomalies.None were found.Ran basal, bolus leaking test as follows: using a new transfer guard and plunger reservoir filled with diluent and connected to a new infusion set.Installed reservoir and connector into a paradigm pump.Conclusion: reservoir no leaks and no air bubbles.(b)(4).

• Brand Name: RESERVOIR 3ML MMT-332A
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; ceiba norte ind. park #50 road; juncos 00777 -386
• MDR Report Key: 10268976
• Report Number: 2032227-2020-145724
• Device Sequence Number: 16993905
• Product Code: FRN
• UDI-Device Identifier: 00643169786547
• UDI-Public: (01)00643169786547(17)230117(10)HG4199F
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 01/17/2023
• Device Model Number: MMT-332A
• Device Catalogue Number: MMT-332A
• Device Lot Number: HG4199F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2020
• Initial Date Received by Manufacturer: 07/08/2020
• Supplement Date Received by Manufacturer: 07/29/2020; 09/25/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 07/30/2020; 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 72