MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2014-01-30 for AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT 446255 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..
[4166063]
Customer reported that a tech was injured while running a patient sample on the affirm assay. The tech cut her finger on a glass shard inside the specimen tube. The wound required basic first aid and the tech will receive follow-up testing for (b)(6).
Patient Sequence No: 1, Text Type: D, B5
[11613755]
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? C) or (2-8? C) for up to 72h. The customer complaint could not be confirmed. No returns were available and no batch number was provided for investigation. An inspection of the use of the product, as directed by the insert, it appears as though the collection site took the dropper tip off when dispensing the atts solution into the sample tube. This is against the procedure and is not to be done. Bd recommends that the collection site follow the procedure as directed in the product insert in order to avoid future injury. Bd qa will continue to monitor. A review of past complaints for this product does not indicate a confirmed trend for this issue. Device was not returned to manufacturer for investigation, see manufacturer narrative below.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001119779-2014-00007 |
| MDR Report Key | 3598848 |
| Report Source | 00,06 |
| Date Received | 2014-01-30 |
| Date of Report | 2014-01-23 |
| Date of Event | 2014-01-06 |
| Date Mfgr Received | 2014-01-06 |
| Date Added to Maude | 2014-01-30 |
| 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 | MEDICAL TECHNOLOGIST |
| 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 | 4103164670 |
| Manufacturer G1 | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. |
| Manufacturer Street | PERIFERICO LUIS DONALDO COLOSIO NO. 579 |
| Manufacturer City | NOGALES 48 |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT |
| Generic Name | DEVICE, SPECIMEN COLLECTION |
| Product Code | LIO |
| Date Received | 2014-01-30 |
| Catalog Number | 446255 |
| Lot Number | UNKNOWN |
| Operator | MEDICAL TECHNOLOGIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. |
| Manufacturer Address | PERIFERICO LUIS DONALDO COLOSIO NO. 579 NOGALES ?84048 MX ?84048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-01-30 |