MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,05 report with the FDA on 2014-07-31 for GCE COMBILITE VALVE manufactured by .
[20322539]
This spontaneous medical device case, concerning an ignition with a cd medical oxygen cylinder fitted with a gce combilite valve, was reported by a pharmacist in (b)(6). On (b)(6) 2014 the patient had been supplied medical compressed oxygen by the pharmacy. When the patient's wife was getting the cylinder from the car boot, she opened top flow valve, then opened the main black cylinder valve, at which point she heard a pop and hissing sound of release of gas. It was accompanied, for an instant, by a blue flame from around the outlet area. For a further 60 to 90 seconds, the cylinder continued to release gas until empty. Whilst other people were in the public area, no other person reacted to or witnessed the incident. The patient's wife declared that no creams or lotions were present on her hands. She subsequently attended the a&e department on (b)(6) where she was treated for a minor abrasion on one of her fingers. The cd cylinder showed signs of blackening around the gauge and back of schrader outlet. Cylinder will be dispatched for analysis and investigation.
Patient Sequence No: 1, Text Type: D, B5
[20499938]
The cod was supplied by boc to (b)(6) on (b)(4) 2014. The pharmacist was informed of incident on saturday (b)(4) 2014. Boc was informed of incident on (b)(4) 2014. Pharmacist declares that patient is heavy smoker and that he has had no previous issues with this patient. All appropriate safety literature and information is provided to all new patients. The cylinder was filled in (b)(4) branch. Cd bar code no: (b)(4). Batch no: 6536849. Expiry date: 08/05/17. The cylinder went into service under its current bar code in february 2012 and has been filled on 17 occasions at the (b)(4) site since then. It was last filled on (b)(6) 2014, having been registered in in-label on the previous day. Batch number of the compressed medical oxygen (6536849, (b)(4)). Expiry date: 8/may/2017. From the in-label records, the valve was manufactured in november 2011 and was fitted to the cylinder at the end of january 2012. The valve number is (b)(4) and there was no indication of any remedial work being done to the valve. The manufacturer, gce, has been notified of the ignition. The cylinder has been returned from (b)(6) and an initial investigation showed internal damage commensurate with the other ignition valves we have had, though the external impact of the ignition was significantly less. The valve has been sent for further internal investigations to try and identify anything untoward concerning the position and fit of the filter. This work has been contracted out to a university in the (b)(4) and is being done in conjunction with gce. Evaluation: valve incident - spontaneous ignition causing minor abrasion on hand of patients wife, valve undergoing extensive investigation in collaboration between (b)(4) and main manufacturer.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2014-00003 |
| MDR Report Key | 4020250 |
| Report Source | 00,01,05 |
| Date Received | 2014-07-31 |
| Date Mfgr Received | 2014-06-30 |
| Date Added to Maude | 2014-08-21 |
| 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 | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Country | UK |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GCE COMBILITE VALVE |
| Generic Name | NONE |
| Product Code | ECX |
| Date Received | 2014-07-31 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-31 |