MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-07 for TUBING, INSUFFLATION 2/ .3 MICR FILT/STRYKER AD 28-0211 manufactured by Deroyal Intercontinental, S.l.r Km7.
[5794090]
Customer reported that the tubing started leaking around the end that plugs into the machine. After follow up with customer, it was reported that the leak occurred towards the middle of the filter housing, but not visual damage to the product was found.
Patient Sequence No: 1, Text Type: D, B5
[13379952]
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 information which changes the content of this report. The original root cause could not be determined since no sample was returned and no remaining inventory of provided lot was available. The original investigation concluded that this could have been an isolated incident since other work orders produced using the same lot of filters were reviewed adn not complaints of leaking were reported.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004605321-2015-00009 |
| MDR Report Key | 4759426 |
| Report Source | 06 |
| Date Received | 2015-05-07 |
| Date of Report | 2015-04-30 |
| Date of Event | 2013-02-19 |
| Date Facility Aware | 2013-02-09 |
| Report Date | 2015-04-30 |
| Date Mfgr Received | 2013-02-19 |
| Device Manufacturer Date | 2012-01-06 |
| Date Added to Maude | 2015-06-12 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | TUBING, INSUFFLATION 2/ .3 MICR FILT/STRYKER AD |
| Generic Name | INSUFFLATION TUBING, TBING W/ FILTER |
| Product Code | NKC |
| Date Received | 2015-05-07 |
| Catalog Number | 28-0211 |
| Lot Number | 27033662 |
| 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 | 2015-05-07 |