MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-07 for HEATED HI-FLOW INSFFULATION TUBING 28-0212H manufactured by Deroyal Intercontinental, S.l. R ,kms, Autopista Joaquin Balaguer.
[5954468]
Customer contacted deroyal sales rep and stated that the tubing "would not flow".
Patient Sequence No: 1, Text Type: D, B5
[13441495]
This report is being filed due to a retrospective review of complaints. This complaint has been re-opened for further investigation. A supplemental report will be filed if further investigation provides information which changes the content of this report. The original root cause was determined to be migration of the plasticizer into the filter housing. It was determined to change the filter material to a polycarbonate material which is stronger, higher impact, and more chemical resistant. It is also less affected by temperature.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004605321-2015-00008 |
| MDR Report Key | 4759429 |
| Report Source | 06 |
| Date Received | 2015-05-07 |
| Date of Report | 2015-04-30 |
| Date of Event | 2012-03-21 |
| Date Facility Aware | 2012-03-12 |
| Report Date | 2015-04-30 |
| Date Mfgr Received | 2012-03-27 |
| Device Manufacturer Date | 2011-04-25 |
| Date Added to Maude | 2015-06-12 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN |
| Manufacturer Country | US |
| Manufacturer Phone | 8653626157 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-2113-2013 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEATED HI-FLOW INSFFULATION TUBING |
| Generic Name | INSUFFLATON TUBING, TBING W/ FILTER |
| Product Code | NKC |
| Date Received | 2015-05-07 |
| Catalog Number | 28-0212H |
| Lot Number | 25356901 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INTERCONTINENTAL, S.L. R ,KMS, AUTOPISTA JOAQUIN BALAGUER |
| Manufacturer Address | PISANO FREE ZONE BUILDING 49 SANTIAGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-07 |