MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2011-01-28 for NONE manufactured by Armstrong Medical Ltd..
[15783581]
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Patient Sequence No: 1, Text Type: D, B5
[15866123]
A white mark is caused by a venting problem with the injection mould that these parts are made from and had been previously deemed acceptable with no risk of further developing into a hole. Investigation of our current stock confirmed the presence of the white mark on the spout but with no holes and that it is not possible for the white mark to become a hole after completion of the moulding process. The cause of the hole was confirmed as being a short, probably restricted to a small number of components moulded the initial start-up of the production run. The formation of a hole is related to the same issue as the cause of the white mark, however it should be noted that the presence of the white mark does not indicate the presence of a hole. The mould was repaired to address the gassing problem by installing an additional venting pin and the first subsequent production run began on (b)(6) 2010. Whilst the components moulded during this run still had a small white mark on the spout, an inspection of over (b)(4) units from this run revealed no holes. These components were therefore accepted for use. Further work on the injection mould was completed in advance of our most recent production run and this has resulted in the reduction of the white mark to a barely visible blemish. As a further precaution we have modified the apparatus used to 100% pressure test the finished g-cans to also pressure test the spout. Product defect was seen as not reportable as there is an alarm system on the anesthetic machine to detect any leakage during pre-use checks. Pre-use checks are recommended before clinical use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9616692-2011-00001 |
| MDR Report Key | 2508706 |
| Report Source | 00,06 |
| Date Received | 2011-01-28 |
| Date Mfgr Received | 2011-01-18 |
| Device Manufacturer Date | 2010-07-01 |
| Date Added to Maude | 2012-05-10 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | WATTSTOWN BUSINESS PARK NEWBRIDGE RD. |
| Manufacturer City | COLERAINE BT521BS |
| Manufacturer Country | EI |
| Manufacturer Postal | BT52 1BS |
| Manufacturer Phone | 870356029 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | NONE |
| Product Code | CBL |
| Date Received | 2011-01-28 |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ARMSTRONG MEDICAL LTD. |
| Manufacturer Address | WATTSTOWN BUSINESS PARK NEWBRIDGE RD. COLERAINE EI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-01-28 |