MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2012-12-05 for MEDICYL-E-LITE manufactured by .
[2951305]
This is a spontaneous near incident with a medical device, reported from a distributor in usa concerning a valve integrated pressure regulator (vipr), on a medicyl e-lite portable oxygen delivery system, (b)(4). Filter size - 40/50 micron (filling port), 20 micron (filter below regulator seat). No patient details have been reported. The device was found to have no flow from its outlet port during an emergency situation with an unknown patient. The healthcare professional immediately accessed another similar device to administer oxygen to the patient. The incident did not involve any patient injuries.
Patient Sequence No: 1, Text Type: D, B5
[10330648]
The device was returned for evaluation on (b)(4) 2012. Initial immediate investigation performed by linde's (b)(4) on (b)(4) 2012, determined that the unit contained an unknown foreign particle lodged externally in the barbed outlet port of the device which prevented flow to the patient. The foreign particle was removed and retained for possible future analysis. The device was then sent to linde's certified repair centre in (b)(4), with instructions to test the returned device against its expected performance specifications. The linde "manufacturer certified repair technician" at our repair centre functionally tested the device on (b)(4) 2012 and determined that the unit passed its tests. Additional testing and visual observations also determined that the device's internal filter was in place and would not have allowed such a foreign particle to ever travel internally to the point where it was found to be lodged. It was also concluded that due to the specific physical size characteristics of the foreign particle, internal diameter of the outlet barbed fitting and in-line filter, the foreign particle originated from an outside source. Also, this device is shipped to the end user with a protective dust cap covering the barbed outlet fitting where it is removed by the end user preceding its use. This cap would have prevented the foreign particle from externally entering the port during the shipping process. Evaluation/conclusion: the investigation concludes that the barbed outlet port of the device may have been bumped against a surface such as a wall or stationary object where the pointed end of the barbed outlet port may have pierced through the surface after its protective dust cap was removed but before it was placed into service. Analysis determined that the black plastic like particle was a different material in hardness and thickness than the protective cap. This piercing action could have created a "slug" of foreign particle originating from the surface it was bumped against. The inside of the attached cylinder was visualised to be clean and free from contamination. This is considered a very rare occurrence. Linde's distributor has decided to add a "flow test" to their existing internal pressure check they perform prior to delivery to the end user in order to assure that each device is checked for positive flow from the barbed outlet port. No additional information is expected. Evaluation: device issue, "foreign body" blocking oxygen flow outlet, cause unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003900188-2012-00003 |
| MDR Report Key | 2861758 |
| Report Source | 08 |
| Date Received | 2012-12-05 |
| Date Mfgr Received | 2012-11-06 |
| Device Manufacturer Date | 2005-06-01 |
| Date Added to Maude | 2013-03-12 |
| 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 Country | SW |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICYL-E-LITE |
| Generic Name | NONE |
| Product Code | ECX |
| Date Received | 2012-12-05 |
| Returned To Mfg | 2012-11-09 |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-12-05 |