MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2019-05-10 for FACTOR VIII CHROMOGENIC ASSAY 10445729 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[145946686]
The customer contacted a siemens customer care center (ccc) and reported that she pierced herself in the hand during the preparation of the factor x part of the factor viii chromogenic assay. Per the procedure at the customer's site, the factor x reagent was dissolved by adding water using a syringe with an injection needle, which was pierced through the closed reagent cap. According to the factor viii chromogenic assay instruction for use (ifu), the factor x reagent is a lyophilized preparation containing approximately 2 nmol of bovine f. X, tris-(hydroxymethyl)-aminomethan (tris) buffer at ph 8 and stabilizers. The contents of the vial have to be dissolved with 2. 0 ml of distilled or deionized water. However, the cap of the vial is not intended to be pierced through, but rather to be unscrewed and removed. The procedure of piercing through the closed reagent cap is an off-label use. The reagent is performing according to specifications. No further evaluation of this device is required.
Patient Sequence No: 1, Text Type: N, H10
[145946687]
The customer reported that she pierced herself in the hand during the preparation of the factor x part of the factor viii chromogenic assay. Per the procedure at the customer site, the factor x reagent has to be dissolved by adding water using a syringe with an injection needle, which has to be pierced through the closed reagent cap. During this procedure, the customer pierced herself in the hand. The customer was wearing protective gloves. The customer went to a medical doctor, but no medical treatment was required. There are no known reports of medical intervention or adverse health consequences due to the customer piercing herself in the hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2019-00049 |
| MDR Report Key | 8600398 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2019-05-10 |
| Date of Report | 2019-05-10 |
| Date of Event | 2019-04-17 |
| Date Mfgr Received | 2019-04-17 |
| Date Added to Maude | 2019-05-10 |
| 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 Contact | CHRISTOPHER AEBIG |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145242740 |
| Manufacturer G1 | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Street | EMIL-VON-BEHRING-STR. 76 |
| Manufacturer City | MARBURG D-35041, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FACTOR VIII CHROMOGENIC ASSAY |
| Generic Name | FACTOR VIII CHROMOGENIC ASSAY |
| Product Code | GGP |
| Date Received | 2019-05-10 |
| Model Number | FACTOR VIII CHROMOGENIC ASSAY |
| Catalog Number | 10445729 |
| Lot Number | 48989 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL-VON-BEHRING-STR. 76 MARBURG D-35041, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-05-10 |