MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2018-10-09 for BD AFFIRM? VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM 446255 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..
[123064199]
Medical device expiration date: unknown. No lot # provided. Device manufacture date: unknown. Investigation summary: bd molecular quality investigated an end user, affirm atts glass user injury (finger puncture) during dispense 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.
Patient Sequence No: 1, Text Type: N, H10
[123064200]
It was reported that while using a bd affirm? Vpiii ambient temperature transport system the technician was placing the sample tube into the device when sharp pieces of the glass ampule penetrated the wall of the device and cut the finger of the technician resulting in exposure to patient sample. The technician received a medical evaluation and was treated for exposure to bloodborne pathogens at an urgent care facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610847-2018-00327 |
| MDR Report Key | 7946720 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2018-10-09 |
| Date of Report | 2018-09-24 |
| Date of Event | 2018-09-13 |
| Date Mfgr Received | 2018-09-17 |
| Date Added to Maude | 2018-10-09 |
| 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 | 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 | 8015652845 |
| 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 | 3 |
| Brand Name | BD AFFIRM? VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM |
| Generic Name | MICROBIOLOGICAL SPECIMEN COLLECTION AND TRANSPORT DEVICE |
| Product Code | LIO |
| Date Received | 2018-10-09 |
| Catalog Number | 446255 |
| Operator | HEALTH PROFESSIONAL |
| 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 |
|---|---|---|---|
| 0 | 0 | 1. Required No Informationntervention | 2018-10-09 |