MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,08 report with the FDA on 2012-10-03 for DEROYAL 28-0201NS manufactured by Deroyal Intercontinental, S.l.r..
[3016402]
The hospital reported that the filter is clogged when they proceed to use it during pt treatment. They have to remove the filter during the procedure to have use of the tubing, which is not suitable for the surgical procedure.
Patient Sequence No: 1, Text Type: D, B5
[10209401]
Describe event or problem: the hosp reported that the filter is clogged when they proceed to use it during pt treatment. They have to remove the filter during the procedure to have use of the tubing, which is not suitable for the surgical procedure. Deroyal: it was concluded that the resin used to manufacture the insufflation tubing was incompatible with heat and time variables that it is exposed to during shipment and sterilization. This causes the plasticizer to migrate from the tubing to the filter housing causing occlusion. Migration resistant material has been chosen and successfully tested for compatibility of exposer to high heat, in (b)(4) 2008, a 100% inspection of the modified device was performed with no defects found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004605321-2012-00010 |
| MDR Report Key | 2784076 |
| Report Source | 06,08 |
| Date Received | 2012-10-03 |
| Date of Report | 2010-02-19 |
| Date of Event | 2010-02-19 |
| Date Facility Aware | 2010-02-19 |
| Report Date | 2010-02-19 |
| Date Reported to Mfgr | 2010-02-19 |
| Date Mfgr Received | 2010-02-19 |
| 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 | 0 |
| 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 | 8659387828 |
| Manufacturer G1 | DEROYAL INTERCONTINENTAL, S.L.R. |
| Manufacturer Street | KM 7, AUTOPISTA JOAQUIN BALAGUER PISANO FREE ZONE, BLDG 49 |
| Manufacturer City | SANTIAGO |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEROYAL |
| Generic Name | HIF - INSUFFLATOR, LAPAROSCOPIC |
| Product Code | NKC |
| Date Received | 2012-10-03 |
| Catalog Number | 28-0201NS |
| Lot Number | 16826501 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INTERCONTINENTAL, S.L.R. |
| Manufacturer Address | DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-10-03 |