MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2014-10-14 for SEDIPLAST AUTOZERO WESTERGREN ESR SYSTEM NP S-1000 manufactured by Lp Italiana Spa.
[19587939]
Polymedco received a customer call stating that while one of their lab techs was inserting a sediplast pipette into the blood filled vial, the top of the pipette popped off and blood sprayed out. The lab tech was not wearing any facial personal protective equipment or using a lab shield. The lab tech was sprayed in the face with blood, sent to the emergency room for a bodily fluid exposure workup and released. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[19977529]
A (b)(4) sediplast pipettes were distributed in the us market in 2014 ytd and there were no other incidents of this nature. In 2013, a safety alert went out highlighting the instructions for use. The instructions for use state that it is important to carefully and gently insert the pipette into the blood filled vial, without holding or blocking the top of the pipette. From 2013-2014 ytd, (b)(4) sediplast pipettes were distributed. An investigation is currently underway to document the probable root cause of the incident and assess if there is any necessary corrective action or safety alert required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2435505-2014-00001 |
| MDR Report Key | 4308389 |
| Report Source | 07,08 |
| Date Received | 2014-10-14 |
| Date of Report | 2014-10-15 |
| Date of Event | 2014-10-03 |
| Date Facility Aware | 2014-10-03 |
| Report Date | 2014-10-15 |
| Date Reported to FDA | 2014-10-15 |
| Date Reported to Mfgr | 2014-10-15 |
| Date Mfgr Received | 2014-10-03 |
| Date Added to Maude | 2014-12-11 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 Street | 510 FURNACE DOCK RD. |
| Manufacturer City | CORTLANDT MANOR NY 10567 |
| Manufacturer Country | US |
| Manufacturer Postal | 10567 |
| Manufacturer Phone | 8004312123 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SEDIPLAST AUTOZERO WESTERGREN ESR SYSTEM |
| Generic Name | SEDIPLAST |
| Product Code | JPH |
| Date Received | 2014-10-14 |
| Returned To Mfg | 2014-10-15 |
| Model Number | NP |
| Catalog Number | S-1000 |
| Lot Number | T0310A |
| ID Number | NP |
| Device Expiration Date | 2015-11-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LP ITALIANA SPA |
| Manufacturer Address | VIA C. REALE, 15/4 - 20157 MILANO IT |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-10-14 |