MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-10-01 for AFFIRM VPIII AMBIENT TERPERATURE TRANSPORT SY 446255 manufactured by Becton Dickinson Infusion Therapy Systems.
[1477079]
Customer was squeezing the atts ampule and a piece of glass pierced the plastic and injured the tech's finger. Basic first aid was administered on (b)(6) 2010 but her finger continued to hurt. Doctor opened the wound and extracted a piece of glass on (b)(6) 2010. She has had no issues since.
Patient Sequence No: 1, Text Type: D, B5
[8771706]
This product contains an ampule of reagent. The ampule is crushed and the reagent is released through a dropper into a pt sample. Returns were unavailable for analysis. The batch history record was reviewed and found to be satisfactory. Bd offers a device called "robogrips" which customers use to crush these ampules. A set of robogrips have been sent to the customer with instructions for use. To better educate customers regarding the use of this product, bd has revised the package insert to add a precaution regarding this type of issue and include a reference for use of the robogrip pliers. Bd will continue to monitor this type of issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2010-00006 |
| MDR Report Key | 1854678 |
| Report Source | 05 |
| Date Received | 2010-10-01 |
| Date of Report | 2010-09-30 |
| Date of Event | 2010-08-31 |
| Date Mfgr Received | 2010-09-09 |
| Date Added to Maude | 2011-04-08 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | CHARLOTTE DANNENFELSER |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164367 |
| Manufacturer G1 | BECTON DICKINSON INFUSION THERAPY SYS |
| Manufacturer Street | PERIF. 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 TERPERATURE TRANSPORT SY |
| Product Code | LIO |
| Date Received | 2010-10-01 |
| Catalog Number | 446255 |
| Lot Number | 0116864 |
| 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 INFUSION THERAPY SYSTEMS |
| Manufacturer Address | PERIF. LUIS DONALDO COLOSIO #579 NOGALES, SONORA 84048 MX 84048 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2010-10-01 |