MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. RESERVOIR 1.8ML MMT-326A; PUMP, INFUSION

Model Number	MMT-326A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2020
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 the reservoir is leaking at o- rings.Customer stated that no crack was found.All components was present.There was no air bubble in reservoir.No harm requiring medical intervention was reported.The reservoir will be returned for analysis.
Additional Manufacturer Narrative
Evaluated 1 random seal reservoir.Performed pre-fill reservoir test per (b)(4).Found reservoir no leakage and no air bubbles anomaly when removing the plunger, performed manual test per (b)(4) appendix g and found plunger torque test result is within acceptance criteria.(b)(4).

• Brand Name: RESERVOIR 1.8ML MMT-326A
• 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: 10187274
• Report Number: 2032227-2020-135520
• Device Sequence Number: 3297771
• Product Code: FRN
• UDI-Device Identifier: 00643169771437
• UDI-Public: (01)00643169771437(17)210809(10)HG2QR44
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• 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
• Report Date (Section B): 07/23/2020

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: 08/09/2021
• Device Model Number: MMT-326A
• Device Catalogue Number: MMT-326A
• Device Lot Number: HG2QR44
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2020
• Initial Date Received by Manufacturer: 06/18/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/24/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 130