MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-05-08 for TUBING, INSU W/ .1 NICR FILT, ECONOMY NS 28-0207NS manufactured by Deroyal Intercontinental, S. L. R..
[5791384]
Customer reported that the filter of the insufflation system is blocked.
Patient Sequence No: 1, Text Type: D, B5
[13424782]
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 info which changes the content of this report. Comparative eval of flow rate of insufflation tubing sets demonstrated that the flow rates for all the tubing sets under test were "identical", including the returned set. Any perceived significant flow reduction in the returned tubing set when being used in the field must have been due to other causes and not due to any deficiencies or obstructions in the tubing set components.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004605321-2015-00010 |
| MDR Report Key | 4762389 |
| Report Source | 08 |
| Date Received | 2015-05-08 |
| Date of Report | 2015-04-30 |
| Date of Event | 2013-05-16 |
| Date Facility Aware | 2013-05-16 |
| Report Date | 2015-04-30 |
| Date Mfgr Received | 2013-05-16 |
| Device Manufacturer Date | 2011-04-25 |
| Date Added to Maude | 2015-06-15 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626157 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUBING, INSU W/ .1 NICR FILT, ECONOMY NS |
| Generic Name | INSUFFLATION TUBING, TUBING W/FILTER |
| Product Code | NKC |
| Date Received | 2015-05-08 |
| Returned To Mfg | 2013-05-22 |
| Catalog Number | 28-0207NS |
| Lot Number | 28508455 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INTERCONTINENTAL, S. L. R. |
| Manufacturer Address | KM 7, AUTOPISTA JOAQUIN BALAQUER PISANO FREE ZON, BLDG 49 SANTIAGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-08 |