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

Model Number	MMT-326A
Medical Device Problem Code	Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
The customer reported via phone call that the reservoir had air bubbles and also had too much pressure.The customer¿s blood glucose was unknown at the time of the incident.The reservoir will be returned for analysis.
Additional Manufacturer Narrative
Evaluated 2 open or used reservoirs.Performed pre-fill reservoir test per dop114-811.Found no air bubbles were observed during analysis.Checked o-rings for defects and none was found.Conclusion: no air bubbles.Also inspected reservoir¿s snap-caps width dimension per dop114-811 and d6014595.Also, using a new lab infusion sets connect found reservoir's snap-caps too loose to connect or lock.

• 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: 8594868
• Report Number: 3004209178-2019-95526
• Device Sequence Number: 19403373
• Product Code: FRN
• UDI-Device Identifier: 00643169771413
• UDI-Public: (01)00643169771413(17)190929(10)HG1CWKA
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/17/2019

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: 09/29/2019
• Device Model Number: MMT-326A
• Device Catalogue Number: MMT-326A
• Device Lot Number: HG1CWKA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 05/03/2019
• Supplement Date Received by Manufacturer: 06/10/2019
• Initial Report FDA Received Date: 05/09/2019
• Supplement Report FDA Received Date: 06/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 60