MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-13 for SEDIPLAST S-1000 manufactured by Lp Italiana.
[65233442]
When the problem was reported to polymedco, polymedco performed testing on retain material for the lot u0738b, using a glycerol solution to mimic consistency of whole blood. None of the tubes that were tested were found defective and all performed acceptably. The actual kit that was used by the laboratory technician was finally returned to polymedco on 08/08/2016 and tested. The 59 tests remaining in the kit of 100 tests were tested with erythrocyte controls and with the glycerol solution. One of the 59 tubes demonstrated leakage of the contents from the top of the tube. Records of incoming quality control testing for the lot were reviewed. The lot passed incoming qc testing, which involves testing of a sample from the lot with the glycerol solution. No physical defects were identified in the inspection sample. Resubmitting mdr 1/13/2017 due to upload errors. Mdr originally uploaded 11/16/2016.
Patient Sequence No: 1, Text Type: N, H10
[65233443]
When using sediplast s-1000 lot u0738b on patient blood, the sample escaped from the top of tube and exposed the laboratory technician to the patient blood, the customer reported that the technician was tested for (b)(6) with negative results. From the report submitted by the user: "while setting up a esr i was splashed in the eye with a patients blood. This was due to a failure of the esr tube top as it allowed the blood to escape the top of the measuring column. The lot number of the device is u0738b. The manufacturer is polymed"
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614769-2017-00001 |
| MDR Report Key | 6251740 |
| Date Received | 2017-01-13 |
| Date of Report | 2016-08-09 |
| Date of Event | 2016-06-13 |
| Date Facility Aware | 2016-07-12 |
| Report Date | 2016-08-09 |
| Date Reported to Mfgr | 2016-08-09 |
| Date Mfgr Received | 2016-07-21 |
| Device Manufacturer Date | 2015-07-01 |
| Date Added to Maude | 2017-01-13 |
| 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 | HELEN LANDICHO |
| Manufacturer Street | 510 FURNACE DOCK ROAD |
| Manufacturer City | CORTLANDT MANOR NY 10567 |
| Manufacturer Country | US |
| Manufacturer Postal | 10567 |
| Manufacturer Phone | 4252600201 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SEDIPLAST |
| Generic Name | ERYTHROCYTE SEDIMENTATION RATE MANUAL TEST; PRODUCT CODE JPH |
| Product Code | JPH |
| Date Received | 2017-01-13 |
| Returned To Mfg | 2016-08-08 |
| Catalog Number | S-1000 |
| Lot Number | U0738B |
| Device Expiration Date | 2017-02-28 |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | R |
| Device Age | 13 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LP ITALIANA |
| Manufacturer Address | VIA CARLO REALE, 15/4 MILANO, LOMBARDY 19643204 IT 19643204 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-13 |