MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-07 for BD AFFIRM? VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM 446255 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..
[144395500]
Medical device expiration date: unknown. Lot #: no lot # provided. Device manufacture date: unknown. Investigation summary: bd molecular quality investigated an end user, affirm atts glass user injury (finger puncture) during dispensing of specimen at an affirm testing facility. It was confirmed that the end user found glass in the specimen collection tube. It was determined that the affirm collection site was not following the affirm atts package insert or affirm collection poster instructions. The collection site was crushing the atts glass ampule (as instructed), opening the atts cap and pouring the glass into the affirm sample collection tube (not instructed). The affirm package insert and affirm collection poster does not instruct collection sites to open the atts vial and pour the glass into the collection tube. Bd has completed an update to the affirm collection poster to provide further clarification on the instructions for use with affirm atts. Bd molecular quality will continue to closely monitor for trends associated with affirm atts glass injury. Investigation conclusion: complaint not confirmed. Root cause description: end user not following procedure. Rationale: complaint not confirmed. No trend (<3 complaints against indicated failure mode for given month).
Patient Sequence No: 1, Text Type: N, H10
[144395501]
This report represents patient 1 of 2: it was reported while using a bd affirm? Vpiii ambient temperature transport system the lab technician broke the glass ampule with a reagent dropper. However, after breaking the glass ampule the lab technician removed the cap and poured the contents into a sample collection tube. The technician did not notice the glass shards in the tube and cut their fingers while squeezing the collection tube. The lab technician was exposed to patient sample through the cuts in their fingers. The lab technician was treated with first aid on site which included rinsing the injury site and bandaging their wounds. Post exposure, the lab technician was tested and then monitored for (b)(6). No indication was given that the patient had contracted a bloodborne illness from the exposure. The following information was provided by the initial reporter: "customer reports two injuries due to the glass ampule in the atts kit. The customer states they were receiving samples from collection sites where the collection sites have correctly broken the glass ampule using the reagent dropper but have removed the cap and poured the contents into the transport/sample collection tube with the patient specimen. The lab explains that they did not notice the glass shards inside the tube and cut their fingers when squeezing the collection tubes as well as when adding the filter tip... End users required only on-site first aid, including rinsing the puncture site and adhering a (b)(6)... End users were potentially exposed to patient bodily fluids and are being monitored and tested for (b)(6). "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610847-2019-00358 |
| MDR Report Key | 8588895 |
| Date Received | 2019-05-07 |
| Date of Report | 2019-04-16 |
| Date of Event | 2019-04-11 |
| Date Mfgr Received | 2019-04-15 |
| Date Added to Maude | 2019-05-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. |
| Manufacturer Street | PERIFERICO LUIS DONALDO COLOSIO NO. 579 |
| Manufacturer City | NOGALES |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD AFFIRM? VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM |
| Generic Name | SPECIMEN COLLECTION AND TRANSPORT DEVICE |
| Product Code | LIO |
| Date Received | 2019-05-07 |
| Catalog Number | 446255 |
| 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 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-05-07 |