MAUDE Adverse Event Report: MEDICAL DEVELOPMENTS INTERNATIONAL COMPACT SPACE CHAMBER PLUS; HOLDING CHAMBERS, DIRECT PATIENT INTERFACE

Model Number SP-SPAP-CE

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

Following our examination of the returned sample and investigations conducted together with our contract manufacturer (including a review of batch records and retention samples), we are unable to determine any manufacturing issue that may have caused the reported event.The silicone material used for the valves is unchanged, and there had been no changes to the design of the valve at the time of the production of this batch.Mdi has no other recorded reports of this type of event occurring, in any other market.In the absence of any manufacturing issues being identified, it is most likely in our view that tearing has been caused during the cleaning of the space chamber.It is possible to damage the valve if the base is removed and the space chamber is cleaned with something like a bottle brush.Pushing though the valve with enough force may initiate tearing of the valve at the cross cut (even using a relatively blunt implement) and this tear may then be propagated through the valve, along any creases/edges in the valve.This does require a reasonable amount of force, and the use of a bottle brush or similar item is not contained in the cleaning instructions provided with the device.The space chamber should only be cleaned according to the process outlined in the instructions for use.

Event Description

(loose translation in english): "during inhalation a piece of the blue valve broke off (the valve is divided into 4 quarters and half of a quarter broke off) and entered the patients mouth.The patient was lucky that it landed in her mouth and not directly in her trachea/windpipe because we do not know what the consequences would have been.It seems life threatening that this can break off.The patient only used the product for one and a half months (but this should not happen even if the usage had been a year or more) and she was very shocked and frightened.".

• Brand Name: COMPACT SPACE CHAMBER PLUS
• Type of Device: HOLDING CHAMBERS, DIRECT PATIENT INTERFACE
• Manufacturer (Section D): MEDICAL DEVELOPMENTS INTERNATIONAL; 4 caribbean drive; scoresby, victoria 3179 ; AS 3179
• Manufacturer (Section G): FOREMOUNT ENTERPRISE CO., LTD.; no. 17, alley 15, lane 5; shenan street; shengang district, taichung city 42944 ; TW 42944
• Manufacturer Contact: brooke ryder-smith ; 4 caribbean drive; scoresby, victoria 3179 ; AS 3179
• MDR Report Key: 7482145
• MDR Text Key: 107704045
• Report Number: 3005977696-2018-00001
• Device Sequence Number: 1
• Product Code: NVP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K122252
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: SP-SPAP-CE
• Device Lot Number: 02-2015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1