MAUDE Adverse Event Report: LEVENTON S.A.U. DOSI-FUSER; ELASTOMERIC INFUSION PUMP

Model Number	250D1
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event has been recorded in (b)(6).Defective units were returned to manufacturer and the presence of white powder on the container surface was confirmed.Three (3) units from the same manufacturing lot were retrieved from retained samples, and the presence of white powder was also observed.However, the batch record of the affected lot number was reviewed and no incidence similar to the one reported was detected in the controls done during the manufacturing process nor in the controls done before the product release.It seems that this powder might be originated by a migration of some of the plastic substances of the container's material, generating a thin layer on the container's surface, but no conclusion can be made yet.
Event or Problem Description
A white powdery film was identified on all the pumps opened for 2 boxes of dosi-fuser 250d2 lot 181171l.All cases/pumps were sequestered and returned to manufacturer.In addition, that same white substance was identified on 2 dosi-fuser 250d1 pumps, lot 181087l, that were returned to the manufacturer as well.This white powder is observed both in the inside and the outside of the transparent container.

• Brand Name: DOSI-FUSER
• Common Device Name: ELASTOMERIC INFUSION PUMP
• Manufacturer (Section D): LEVENTON S.A.U.; newton, 18-24; sant esteve sesrovires, barcelona 08635 ; SP 08635
• MDR Report Key: 7937876
• Report Number: 9611707-2018-00039
• Device Sequence Number: 11330150
• Product Code: MEB
• UDI-Device Identifier: 08436020762178
• UDI-Public: 08436020762178
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K040752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/05/2018

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: No Information
• Device Expiration Date: 05/18/2020
• Device Model Number: 250D1
• Device Catalogue Number: L25915-250D1-USA
• Device Lot Number: 181087L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1