MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2014-04-29 for OXYGEN & AEROSOL THERAPY 1003MMUE manufactured by Convatec Limited.
[4508649]
It is reported that the hole in the valve is too small preventing the correct flow rate of air to pass through the venturi valve.
Patient Sequence No: 1, Text Type: D, B5
[12044662]
Based on the available info, this event is deemed a reportable malfunction. There were no reports of the pt being harmed as a result of this malfunction. Investigation performed on (b)(4) 2011 by (b)(4) based on the eval of sample rec'd are as follows: "following the results of the o2% testing we were satisfied that the jet was not functionally unsafe; however, we needed to ascertain why we were getting partially blocked jets. A through examination under magnification of the moulding tool revealed some damage to one of the mould cavities. This was not visible to the naked eye. This damage must have occurred shortly before or during the run that produced the jets used in this batch as the mfg records from previous batches did not show any abnormalities and there have been no adverse incidents reported since the moulding tool was repaired in (b)(4) 2010. The mfg records for this batch did not show any marked abnormalities either but the qc inspection looks for o2% and partially blocked jets do still produce 28% o2. Our tool maker has not looked at the tool and has suggested a modification to prevent further incidents of this nature. We have agreed with his proposal and the tool maker is now making the modification which will then be validated before any further 28% jets are released into production. " note: this mdr is being reported as a result of a retrospective review of complaints conducted by convatec for complaints rec'd from (b)(6) 2013. Convatec will continue to track and monitor such complaints according to convatec inc's. Complaint handling and capa procedures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1000317571-2014-00023 |
| MDR Report Key | 3869086 |
| Report Source | 01,05,06,07 |
| Date Received | 2014-04-29 |
| Date of Report | 2011-05-05 |
| Date of Event | 2011-05-05 |
| Date Mfgr Received | 2011-05-05 |
| Date Added to Maude | 2014-06-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, INTERIM ASSOCI |
| Manufacturer Street | 200 HEADQUARTERS PARK DRIVE |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OXYGEN & AEROSOL THERAPY |
| Generic Name | MASK, O2 LOW CONCENTRATION, VENTURI |
| Product Code | BYF |
| Date Received | 2014-04-29 |
| Returned To Mfg | 2011-05-16 |
| Model Number | 1003MMUE |
| Catalog Number | 1003MMUE |
| Lot Number | 3120183-3 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC LIMITED |
| Manufacturer Address | FIRST AVENUE DEESIDE INDUSTRIAL PARK DEESIDE, FLINTSHIRE CH52NU UK CH5 2NU |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-29 |