MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-04-13 for TUBING, INSUF W/ .1 MICR FLT, ECONOMY 28-0207 manufactured by Deroyal Intercontinental, S.l.r. Km7.
[5716623]
Co2 could not flow thru the filter.
Patient Sequence No: 1, Text Type: D, B5
[13192485]
When the report was received the qc complaint specialist contacted the qc to request a copy of the work order for a review on (b)(6)2013. The work order was supplied for review on (b)(6) 2013. The review of the work order identified that raw material products subjected to an in process inspection and was documented on the in-process inspection report, (b)(4) testing was also performed and documented within the work order. A total of 125 tests were conducted and all passed. The actual sample from the customer and representative samples from the same lot number was provided to deroyal engineering for evaluation. Refer to the corp. Pcl. 016 summary report attachment. Correction: a replacement has been provided on order # 3270600. Root cause analysis: the customer's report of the product having a filter issue is unable to be confirmed. The complaint item and the additional products reviewed of the same lot number passed all testing and the acceptance criteria which the fda defines as a safe and effective flow rate. The additional testing of the representative samples and results gathered, confirm the filters and tubing allow sufficient flow of the co2 gas to establish and maintain pneumoperitoneum. Corrective action and/or systemic correction action taken: due to the root cause determination a corrective action has not been taken. Preventive action: a preventive action has not been taken. No further information available at this time. The investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004605321-2015-00003 |
| MDR Report Key | 4688264 |
| Report Source | 05 |
| Date Received | 2015-04-13 |
| Date of Report | 2015-04-09 |
| Date of Event | 2013-12-03 |
| Date Facility Aware | 2013-12-03 |
| Report Date | 2015-04-09 |
| Date Mfgr Received | 2013-12-03 |
| Device Manufacturer Date | 2013-09-01 |
| 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 | TUBING, INSUF W/ .1 MICR FLT, ECONOMY |
| Generic Name | TUBING/TUBING W/FILTER INSUFFLAT LAP |
| Product Code | NKC |
| Date Received | 2015-04-13 |
| Returned To Mfg | 2013-12-09 |
| Catalog Number | 28-0207 |
| Lot Number | 32847601 |
| Device Expiration Date | 2018-07-20 |
| 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 BALAGUER PISANO FREE ZONE, BLDG 49 SANTIAGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-04-13 |