MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-05-17 for ORS-320 SLUSH WARMER DISC DRAPE manufactured by Microtek Dominicana, S.a..
[108616839]
At the time of this report, no additional information has been received to indicate the patient developed an infection. A sample was received for evaluation. The drape was placed over a warmer with water added. Drape was left on the warmer for over 1 hour. No leaks, tears, holes or burn marks were found. The dhr was reviewed and it was noticed that this lot had (b)(4) pieces that were manufactured from 09/17/17 to 09/19/17. No defects related to the nonconformance were reported during quality inspections. Based on the device history record and sample review, this does not appear to be the result of a personnel, process or material issue as no leaks, tears, holes or burn marks were found. Since the reported issue was no found in review of the sample and no defects were reported during quality inspection, no additional actions will be taken at this time.
Patient Sequence No: 1, Text Type: N, H10
[108616840]
Company rep reported "i had the drape from the case but they want to keep it in case they need to do an investigation on their end. I am sending another drape in the lot. I want to send in a drape from the lot to be checked. I met with the clinical manager, scrub tech, and infection prevention. There is a small, but fast leaking hole in the warmer end. This occurred last monday. Testing the warmer, had minimum fluid, didn't use suction on the drape, etc. Patient was under observation and no signs of related infection. In-service scheduled for (b)(6) and recommended intratemp as an alternative product. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2018-00019 |
| MDR Report Key | 7524015 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-05-17 |
| Date of Report | 2018-04-20 |
| Date of Event | 2018-04-16 |
| Date Mfgr Received | 2018-04-20 |
| Date Added to Maude | 2018-05-17 |
| 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 Contact | MRS JENNIFER MRKVICKA |
| Manufacturer Street | 1 ECOLAB PLACE |
| Manufacturer City | ST. PAUL MN 55102 |
| Manufacturer Country | US |
| Manufacturer Postal | 55102 |
| Manufacturer Phone | 6512502237 |
| Manufacturer G1 | MICROTEK DOMINICANA |
| Manufacturer Street | ZONA FRANCA NO. 2 |
| Manufacturer City | LA ROMANA, |
| Manufacturer Country | DR |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORS-320 SLUSH WARMER DISC DRAPE |
| Generic Name | FLUID WARMING AND SLUSH DRAPES |
| Product Code | LHC |
| Date Received | 2018-05-17 |
| Returned To Mfg | 2018-04-27 |
| Model Number | ORS-320 |
| Lot Number | D172591 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICROTEK DOMINICANA, S.A. |
| Manufacturer Address | ZONA FRANCA NO. 2 LA ROMANA, DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-17 |