MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-04-10 for AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT 446255 manufactured by Becton, Dickinson.
[4465027]
An employee at the (b)(6) was handling the affirm atts product and accidently inhaled it. The employee was holding the atts ampule up in the air, level with her face and fairly close to nose and she was adding the liquid preservative to the collection tube. She was handling the product bedside in the exam room. She was not wearing safety glasses nor was she working under a hood at the time of the event. The tech immediately noted a metallic taste in her mouth. Within a time frame of 12-24 hours post exposure, the tech began to experience chest pains. She went to the er where cardiac issues were ruled out. A chest x-ray was performed and that was negative. Two days after the tech visited the er, she was still experiencing discomfort in her chest. She visited an urgent care center. She was diagnosed with pleurisy and was subsequently treated with oral steroids and pain medication. The occupational health nurse has also reported that since treatment the employee is feeling better.
Patient Sequence No: 1, Text Type: D, B5
[11850935]
The affirm atts collection kit is used to stabilize the nucleic acid of candida species, gardnerella vaginalis, and trichomonas vaginalis during specimen transport at ambient temperature (15-30 degrees c) or (2-8 degrees c) for up to 72 hours. The affirm atts package insert indicates the product is toxic, highly flammable, and is irritating to eyes, respiratory system and skin. It instructs users to use the product in a well-ventilated area and to wear protective clothing and gloves. If inhaled, the package insert indicates to supply fresh air or oxygen, to consult the material safety data sheet (msds) and to see medical advice. The msds indicates that this product has a health rating of 2 and is toxic by inhalation, in contact with skin and if swallowed. The product contains dimethylsulfoxide (dmso) which is a known lung irritant. The first aid section of the msds provides the following instructions: "after inhalation supply fresh air or oxygen; and immediately call for a doctor. " bd quality completed a review of past complaints for this product and found no trend for this issue. Bd quality will continue to monitor complaints for this type of issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2014-00009 |
| MDR Report Key | 3760975 |
| Report Source | 05 |
| Date Received | 2014-04-10 |
| Date of Report | 2014-03-27 |
| Date of Event | 2014-03-21 |
| Date Mfgr Received | 2014-03-27 |
| Date Added to Maude | 2014-04-22 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | PERIFERICO LUIS DONALDO COLODIO #579 |
| Manufacturer City | NOGALES, SONORA, C.P. 84000 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84000 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT |
| Product Code | LIO |
| Date Received | 2014-04-10 |
| Catalog Number | 446255 |
| Lot Number | UNK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON |
| Manufacturer Address | NOGALES, SONORA, C.P. MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-04-10 |