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 2018-01-16 for ORS-320 SLUSH WARMER DISC DRAPE manufactured by Microtek Dominicana, S.a..
[97879224]
A sample was received for evaluation. The drape had a small hole 22 inches from the slush plate and 7 inches to the left. Not where the drape would sit in the basin. The dhr was reviewed and it was noticed that this lot had 2400 pcs that were manufactured on 05/02/2017. No defects related to the nonconformance were reported during quality inspections. The personnel were trained. The production line this product was manufactured on has since been discontinued. The current production line was reviewed and nothing was found that could create a hole in the drape. Additionally, the method at the current production line was reviewed and it was confirmed that the operators follow the process. It was concluded that the sample sent by the customer confirmed the original complaint/description of the problem. In the sample a pinch was noticed at the hole. This pinch rises up from the bottom part of the drape and this indicates that the edges of the oven (warmer) were sharp. The location of the hole is in the same area.
Patient Sequence No: 1, Text Type: N, H10
[97879225]
Cleaned and decontaminated the drape so that it can be handled. When we draped the machine the hole was near the corner of the warmer. However, there was a liter of fluid that leaked into the warmer basin. The edges of the warmer are sharp and she plans to put some duct tape on the corners to smooth them out until replacements are received. We aren't sure that is what happened but one possibility. No patient injury or treatment was reported for the incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043817-2018-00002 |
| MDR Report Key | 7197080 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-01-16 |
| Date of Report | 2017-12-18 |
| Date of Event | 2017-12-15 |
| Date Mfgr Received | 2017-12-18 |
| Date Added to Maude | 2018-01-16 |
| 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 | 2018-01-16 |
| Returned To Mfg | 2018-01-02 |
| Model Number | ORS-320 |
| Lot Number | D171211 |
| 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 | 2018-01-16 |