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 2018-01-11 for BD AFFIRM? VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM 446255 manufactured by Bd Infusion Therapy Systems Inc. S.a. De C.v..
[97009289]
Investigation: investigation summary: bd molecular quality previously 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. Quality investigation required review of the affirm atts package insert and affirm collection poster. Per review of the affirm package insert & collection poster, 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 of use with affirm atts. Bd molecular quality will continue to closely monitor for trends associated with affirm atts glass injury. Investigation conclusion: not confirmed. Customer education issue. Root cause description: off-label use.
Patient Sequence No: 1, Text Type: N, H10
[97009290]
It was reported that a technician experienced a puncture from glass from a bd affirm? Vpiii ambient temperature transport system during the filtering step of the process.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610847-2017-00240 |
| MDR Report Key | 7183459 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2018-01-11 |
| Date of Report | 2018-01-03 |
| Date of Event | 2017-12-18 |
| Date Mfgr Received | 2017-12-19 |
| Device Manufacturer Date | 2017-08-31 |
| Date Added to Maude | 2018-01-11 |
| 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 | 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 | DIRECT TESTING/SEROLOGY |
| Product Code | LIO |
| Date Received | 2018-01-11 |
| Catalog Number | 446255 |
| Lot Number | 7243600 |
| Device Expiration Date | 2018-11-24 |
| 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 | 2018-01-11 |