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 2016-10-31 for VIDAS? MEASLES IGG ASSAY 30219 manufactured by Biomerieux Sa.
[58851968]
Device not returned to manufacturer.
Patient Sequence No: 1, Text Type: N, H10
[58851969]
A customer in (b)(6) contacted biom? Rieux to report they observed a leaking vial for the control 1 reagent contained in a vidas? Measles igg assay kit. The customer stated that no personnel were harmed as a result of the leaking vial. The user was reminded of the proper precautions regarding personal protective equipment when handling the vial. Though the associated msds indicates "no dangerous reaction known under conditions of normal use", it also states products contained within the kit can cause serious eye damage/irritation. The package insert for the product states "wipe up spills thoroughly after treatment with liquid detergent and a solution of household bleach containing at least 0. 5% sodium hypochlorite (10% bleach) to inactivate infectious agents. Evaluation of complaint records indicates no other reports of leaking vidas? Measles igg control vials. An internal biom? Rieux investigation will be initiated.
Patient Sequence No: 1, Text Type: D, B5
[63925641]
A customer in (b)(6) contacted biom? Rieux to report they observed a leaking vial for the control 1 reagent contained in a vidas? (b)(6) igg assay kit. An internal biom? Rieux investigation was performed. The complaint concerns the vidas? Msg lot 1004735420 / 170201-0. Upon the opening of the box, the customer found the c1 vial vidas? Msg lot 1116180 reversed and badly screwed with a leak. The analysis of batch history records of vidas? Msg lot 1004735420 / 170201-0 showed no anomaly during the packaging. The analysis of batch history records of the c1 vial vidas? Msg lot 1116180 showed no anomaly during the filling. The quality control performed a serological control on vidas? Msg c1 lot 1116180. (b)(6) serology and the results were (b)(6) as mentioned in the package insert. "this product has been tested and shown to be (b)(6) for (b)(6) surface antigen, and antibodies to (b)(6). However, since no existing test method can totally guarantee their absence, this product must be treated as potentially infectious. Therefore, usual safety procedures should be observed when handling". The quality control laboratory checked the retain kit vidas? Msg lot 1004735420 / 170201-0: the vials were correctly screwed. There is no other complaint on the vidas? Msg lot 1004735420 / 170201-0 for the same issue. There is no capa or non-conformity for a similar issue. The quality product laboratory recommend to the customer to wear gloves when handling reagents in accordance with good laboratory practices. A communication to the filling department will be performed informing them about this complaint.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3002769706-2016-00456 |
| MDR Report Key | 6067731 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2016-10-31 |
| Date of Report | 2016-10-04 |
| Date Mfgr Received | 2016-10-04 |
| Device Manufacturer Date | 2016-03-17 |
| Date Added to Maude | 2016-10-31 |
| 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 | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. ELLEN WELTMER |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3147317301 |
| Manufacturer G1 | BIOMERIEUX, INC |
| Manufacturer Street | 595 ANGLUM ROAD |
| Manufacturer City | ST. LOUIS MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIDAS? MEASLES IGG ASSAY |
| Generic Name | VIDAS? MEASLES IGG ASSAY |
| Product Code | LJB |
| Date Received | 2016-10-31 |
| Catalog Number | 30219 |
| Lot Number | 1004735420 |
| Device Expiration Date | 2017-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMERIEUX SA |
| Manufacturer Address | CHEMIN DE L ORME MARCY L ETOILE, RHONE 69280 FR 69280 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-31 |