MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-11-20 for AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT SY 446255 manufactured by Becton Dickinson Infusion Therapy Systems.
[1393323]
Customer was squeezing the atts ampule and a piece of glass pierced the plastic and injured the tech's finger. She was given basic first aid and sent to a workman's comp facility. They lanced her finger to remove glass that was still there and gave her antibiotics as a precaution. The tech called out of work the next day due to the pain and commented regarding a question of whether there was damage to the tendon which may require physical therapy.
Patient Sequence No: 1, Text Type: D, B5
[8336796]
This product contains an ampule of reagent. The ampule is crushed and the reagent is released through a dropper into a pt sample. The customer was unable to provide a specific lot number of product which was used when this incident occurred. No further investigation can be completed with retention material. Bd offers a device called "robogrips" which customers use to crush these ampules. Further conversation with the customer revealed they are aware of the product, but never thought they were necessary because they have never had a problem before. Info regarding the robogrips has been sent to the customer for further consideration. To better educate customers regarding the use of this product, bd will be revising 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 | 1119779-2009-00010 |
| MDR Report Key | 1546587 |
| Report Source | 05 |
| Date Received | 2009-11-20 |
| Date of Report | 2009-11-20 |
| Date of Event | 2009-10-28 |
| Date Mfgr Received | 2009-10-28 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JAMES TILLMAN |
| Manufacturer Street | 7 LOVETON CIR. |
| Manufacturer City | SPARKS MD 21152 |
| Manufacturer Country | US |
| Manufacturer Postal | 21152 |
| Manufacturer Phone | 4103164054 |
| Manufacturer G1 | BECTON DICKINSON INFUSION THERAPY SYSTEMS |
| Manufacturer Street | PERIF. LUIS DONALDO COLOSIO #579, NOGALES |
| Manufacturer City | 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 TEMPERATURE TRANSPORT SY |
| Product Code | LIO |
| Date Received | 2009-11-20 |
| Catalog Number | 446255 |
| Lot Number | UNK |
| 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 | 2009-11-20 |