MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,foreign report with the FDA on 2018-05-02 for COMPACT SPACE CHAMBER PLUS SP-SPAP-CE manufactured by Medical Developments International.
[107704045]
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.
Patient Sequence No: 1, Text Type: N, H10
[107704046]
(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. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005977696-2018-00001 |
| MDR Report Key | 7482145 |
| Report Source | CONSUMER,FOREIGN |
| Date Received | 2018-05-02 |
| Date of Report | 2016-04-06 |
| Date Mfgr Received | 2016-04-06 |
| Device Manufacturer Date | 2015-02-01 |
| Date Added to Maude | 2018-05-02 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PHARMACIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BROOKE RYDER-SMITH |
| Manufacturer Street | 4 CARIBBEAN DRIVE |
| Manufacturer City | SCORESBY, VICTORIA 3179 |
| Manufacturer Country | AS |
| Manufacturer Postal | 3179 |
| Manufacturer G1 | FOREMOUNT ENTERPRISE CO., LTD. |
| Manufacturer Street | NO. 17, ALLEY 15, LANE 5 SHENAN STREET |
| Manufacturer City | SHENGANG DISTRICT, TAICHUNG CITY 42944 |
| Manufacturer Country | TW |
| Manufacturer Postal Code | 42944 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMPACT SPACE CHAMBER PLUS |
| Generic Name | HOLDING CHAMBERS, DIRECT PATIENT INTERFACE |
| Product Code | NVP |
| Date Received | 2018-05-02 |
| Model Number | SP-SPAP-CE |
| Lot Number | 02-2015 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL DEVELOPMENTS INTERNATIONAL |
| Manufacturer Address | 4 CARIBBEAN DRIVE SCORESBY, VICTORIA 3179 AS 3179 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-02 |