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 TUBING, INSUF W/ .1 MICR FILT, ECONOMY 28-0207 manufactured by Deroyal Intercontinental, S.l.r Km7.
[5954467]
Customer reported that the lumen of the filter was much smaller than other filters. This was noticed when there was an issue with the intake of co2 during a laparoscopic procedure.
Patient Sequence No: 1, Text Type: D, B5
[13441494]
This report is being filed due to a retrospective review of complaints. This complaint has been re-opened for filed for further investigation. A supplemental report will be filed if further investigation provides information which changes the content of this report. The filter was returned as was visibly damaged as shown through side-by-side comparison with other filters. The product was significantly damage, but the root cause could not be determined. Potential causes could be damage during shipment/storage, user error, improper storage.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004605321-2015-00011 |
| MDR Report Key | 4759427 |
| Report Source | 06 |
| Date Received | 2015-05-07 |
| Date of Report | 2015-04-30 |
| Date of Event | 2014-01-27 |
| Date Facility Aware | 2014-01-27 |
| Report Date | 2014-04-30 |
| Date Mfgr Received | 2014-01-30 |
| Device Manufacturer Date | 2012-02-05 |
| 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 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, INSUF W/ .1 MICR FILT, ECONOMY |
| Generic Name | INSUFFLATION TUBING, TBING W/FILTER |
| Product Code | NKC |
| Date Received | 2015-05-07 |
| Returned To Mfg | 2014-03-27 |
| Catalog Number | 28-0207 |
| Lot Number | 27812113 |
| 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 KM7 |
| Manufacturer Address | AUTOPISTA JOAQUIN BALGUER PISANO FREE ZONE, BUILDING 49 SANTIAGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-07 |