MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-04-13 for HEATED HI-FLOW INSUFFL TUBING 28-0212H manufactured by Deroyal Intercontinental, S.l.r. Km7.
[5716132]
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
[13132597]
Investigation findings: when the report was initially received it was determined that a joint investigation with branch plant 65 would be required. The complaint was forwarded to the qc for the joint investigation. Upon completion of the qc investigation the call was returned to the qc complaint specialist. When the joint investigation was received by the qc complaint specialist additional information was requested to complete the investigation process. The additional information was received and the evidence of the training and eco was attached to the complaint file. Correction: replacements have been provided on order # 3498931. Root cause analysis: pictures of the kinked was received and evaluated by qc manager besides a meeting was held to address the issue with the following personnel: sales representative, senior qa manager, packaging engineer, director of manufacturing international operations among others; the conclusion as to why pieces got kinked was basically due to the packing method used. Corrective action and/or systemic correction action taken: a new packaging method was developed to help in the prevention of kink on the tubing. The new method packaging will consist in coiling the pieces in a more circular way rather than a previous oval used to be packed these tubing; besides a new paper band will hold the tubing in a different manner as well. Refer to the coileo attachment for training documentation of the new coiling method and eco 39798 summary attachment as evidence of the band change. 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. Refer to the eco 39798 summary attachment. No further information available at this time. The investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004605321-2015-00006 |
| MDR Report Key | 4688224 |
| Report Source | 06 |
| Date Received | 2015-04-13 |
| Date of Report | 2015-04-09 |
| Date of Event | 2014-12-02 |
| Date Facility Aware | 2014-12-02 |
| Report Date | 2015-04-09 |
| Date Mfgr Received | 2014-12-05 |
| Device Manufacturer Date | 2014-08-01 |
| Date Added to Maude | 2015-06-02 |
| 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 | 8653622333 |
| 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 | 2015-04-13 |
| Catalog Number | 28-0212H |
| Lot Number | 36645741 |
| Device Expiration Date | 2019-07-17 |
| 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. KM7 |
| Manufacturer Address | AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BLDG 49 SANTIAGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-04-13 |