MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-05-06 for AFFIRM VPIII MICRBIAL IDENTIFICATION TEST 446252 manufactured by Becton Dickinson Caribe Ltd..
[20452853]
A technician at the perry count hospital was removing the cap from a patient sample when the sample accidentally splashed into their eye. The technician was not wearing safety glasses. Sample contained lysis solution. Patient sample had been previously heated per the package insert for the affirm vpiii microbial identification test. The tech immediately rinsed the affected eye which appeared irritated after flushing. The tech was then sent to the er to be evaluated. No further treatment was rendered. The physician conducted an exam and felt the flushing was sufficient. The technician reported that the affected eye appeared normal (no redness or irritation) the very next day. Additionally, the customer was sent an sds for the affirm vpiii microbial identification test.
Patient Sequence No: 1, Text Type: D, B5
[20534693]
The affirm vpiii microbial identification test is a dna probe test intended for use in the detection and identification of candida species, gardnerella vaginalis and trichomonas vaginalis nucleic acid in vaginal fluid specimens from patients with symptoms of vaginitis/vaginosis. The affirm vpiii microbial identification test package insert indicates that reagents could ge irritating or caustic if allowed to come into contact with skin, eyes, or mucous membranes. It instructs users to wear protective clothing and safety classes. If contact is made with the ye, the package insert directed the user to flush eye with copious amounts of water. The safety data sheet (sds) indicates a health rating of 2 and is an irritant to both skin and eyes. The first aid section of the sds provides the following instructions: "after eye contact, rinse opened eye for several minutes under running water. If symptoms persist, consult a doctor". Bd quality investigated customer complaint and was unable to replicate sample splashing. Bd quality noted after lysis addition, the sample volume is low (-400ul). Sample cap removal was conducted under multiple scenarios including the use of excessive force and no splash was produced. Bd quality completed a review of past complaints for this product and found no trend for this issue but will continue to monitor for trends.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647876-2015-00002 |
| MDR Report Key | 4763112 |
| Report Source | 05 |
| Date Received | 2015-05-06 |
| Date of Report | 2015-04-08 |
| Date of Event | 2015-04-08 |
| Date Mfgr Received | 2015-04-08 |
| Device Manufacturer Date | 2015-01-01 |
| Date Added to Maude | 2015-05-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BECTON DICKINSON |
| Manufacturer Street | VICKS DR., LOT #6 |
| Manufacturer City | CAYEY PR 00737 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00737 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFFIRM VPIII MICRBIAL IDENTIFICATION TEST |
| Product Code | MLA |
| Date Received | 2015-05-06 |
| Catalog Number | 446252 |
| Lot Number | 5013539 |
| Device Expiration Date | 2015-10-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON CARIBE LTD. |
| Manufacturer Address | VICKS DR., LOT #6 CAYEY PR 00634 US 00634 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-05-06 |