MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-03 for DEROYAL INSUFFLATION TUBING TUBING W/ 0.1UM FIL 28-0207 manufactured by Deroyal Intercontinental.
[3023360]
Customer states no air flow through the tubing. Tubing defective.
Patient Sequence No: 1, Text Type: D, B5
[10270237]
Customer states insufflation tubing will not allow co2 to flow through. Surgery was delayed while replacement tubing was located. This incident occurred several times. (b)(4). Problem was found to be a migrating plasticizer that clogged the filter and prevented the co2 from flowing.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004605321-2012-00013 |
| MDR Report Key | 2822018 |
| Report Source | 05,06 |
| Date Received | 2012-10-03 |
| Date of Report | 2012-10-03 |
| Date of Event | 2010-05-10 |
| Date Mfgr Received | 2010-05-10 |
| Date Added to Maude | 2013-01-18 |
| 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 | 8002519864 |
| Manufacturer G1 | DEROYAL INTERCONTINENTAL |
| Manufacturer Street | KM 7, AUTOPISTA JOAQUIN PISANO FREE ZONE |
| Manufacturer City | SANTIAGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL INSUFFLATION TUBING |
| Generic Name | PRODUCT CODE - HIF, INSUFFLATION TUBING |
| Product Code | NKC |
| Date Received | 2012-10-03 |
| Returned To Mfg | 2010-05-25 |
| Model Number | TUBING W/ 0.1UM FIL |
| Catalog Number | 28-0207 |
| Lot Number | NOT GIVEN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INTERCONTINENTAL |
| Manufacturer Address | SANTIAGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-03 |