MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2015-07-22 for AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT 446255 manufactured by Becton Dickinson.
[21186620]
The customer reported that while processing an affirm vpiii ambient temperature transport tube which was inoculated with patient sample, a shard of glass pierced through the plastic and cut a technician's finger. The wound was cleaned out with soap and water, a bandage was applied and the technician sought medical attention for possible exposure to body fluid. The patient, who was the source of the sample, and the technician were both tested for (b)(6), (b)(6) and (b)(6). All tests were (b)(6). The customer reports that the technician is doing fine.
Patient Sequence No: 1, Text Type: D, B5
[21505498]
Affirm vpiii ambient temperature transport is a sterile ready-to-use system intended for the collection, transport and preservation of vaginal specimens for use only with the affirm vpiii microbial identification test. The affirm vpii ambient temperature transport system (atts) should be used with those specimens where transport times are expect to exceed 1 h at ambient temperature (15-30c) or 4 h at refrigerated temperatures (2-8c). Bd molecular quality initiated investigation on the customer report regarding a atts glass injury when squeezing an affirm specimen. Review of the package insert confirms that the end user was likely not following the correct atts collection procedure. When using the atts, the end user is instructed to break the glass atts ampule within it's plastic protective sheath and dispense the atts solution into the specimen tube. In this case, the glass was found inside the specimen tube. Glass in the specimen tube should not be possible unless the end user removed the atts cap incorrectly pours the glass into the specimen tube. Review of the last year of complaint data reveals this is an isolated incident. Bd molecular quality will continue to closely monitor for trends associated with atts glass injury. There was no corrective action taken at this time.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610847-2015-00001 |
| MDR Report Key | 4939616 |
| Report Source | 05 |
| Date Received | 2015-07-22 |
| Date of Report | 2015-07-22 |
| Date of Event | 2015-06-22 |
| Date Mfgr Received | 2015-06-23 |
| Date Added to Maude | 2015-07-27 |
| 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 CIRCLE |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer Street | PERIFERICO LUIS DONALDO COLOSIO # 579 |
| Manufacturer City | NOGALES, SONORA 84048 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 84048 |
| 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 | 2015-07-22 |
| Catalog Number | 446255 |
| Lot Number | 4234549 |
| Device Expiration Date | 2016-02-25 |
| 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 |
| Manufacturer Address | NOGALES, SONORA MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-22 |