MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-08 for HEATED HI-FLOW INSUFFL TUBING 28-0212H manufactured by Deroyal Intercontinental S. L. R..
[18289175]
The insufflation tubing had a "kink" in the tubing, causing a "blockage" of the co2 gas needed to inflate the abdomen. Therefore, not enough gas was passing through.
Patient Sequence No: 1, Text Type: D, B5
[18645241]
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. Original report indicated pictures of the kinked tubing were received and evaluated. It was determined the cause of the kinking was due to the packaging method used. Corrective action and/or systemic correction action taken: a new packaging method was developed to help in the prevention of kinking of the tubing. The new method packaging will consist in coiling and pieces in a more circular way rather than a previous oval used to be packed these tubing; in addition,k a new paper band will hold the tubing in a different manner as well. Preventive action: the process in which the device is being coiled has been updated and a change has been made to the bom for an alternate band. No further info available at this time. The investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004605321-2015-00012 |
| MDR Report Key | 4762391 |
| Report Source | 06 |
| Date Received | 2015-05-08 |
| Date of Report | 2015-04-30 |
| Date of Event | 2014-09-11 |
| Date Facility Aware | 2014-09-11 |
| Report Date | 2015-04-30 |
| Date Mfgr Received | 2014-09-11 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-06-16 |
| 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 | HEATED HI-FLOW INSUFFL TUBING |
| Generic Name | TUBING/TUBING W/FILTER INSUFFLAT LAP |
| Product Code | NKC |
| Date Received | 2015-05-08 |
| Catalog Number | 28-0212H |
| Lot Number | 35640366 |
| 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. |
| Manufacturer Address | KM7, AUTOPISTA JOAQUIN BALAQUER, PISANO FREE ZONE, BLDG 49 SANTIAGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-08 |