MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-31 for AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT 446255 manufactured by Becton Dickinson Infusion Therapy Systems.
[2941064]
A technician was processing a specimen for testing on the affirm system. The facility receives samples from many different doctors offices. This particular sample had shards of glass in it which the customer theorizes came from the broken transport ampule at the collection site with the glass making its way into the sample tube. The tech at the testing site cut her finger when she was squeezing the tube to dispense the sample for testing. The cut came from a shard of glass that poked through the plastic tube. The cut was washed and bandaged using basic first aid.
Patient Sequence No: 1, Text Type: D, B5
[10305614]
This product contains an ampule of reagent. The ampule is crushed and the reagent is released through a dropper into a patient sample. Returns were unavailable for analysis. A review of the complaint notes indicates a misuse of the product where the procedure, in the product insert, was not followed at the point of specimen collection. The presence of glass in the collection tube would indicate that the dropper tip was removed when dispensing the transfer reagent into the collection tube. If the procedure, as indicated in the product insert, was followed, no glass would've been present in the tube. A review of the manufacturing process and components used indicates that no changes have been made which could cause this defect. A review of past complaints did not reveal a confirmed trend for this batch. All contents in the collection tube should be treated as pathogenically hazardous material, as instructed in the package insert "warning: pathogenic microorganisms, including hepatitis viruses and human immunodeficiency virus, may be present in clinical specimens. "standard precautions" and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids. " the complaint is not confirmed for any product defect. Bd will continue to monitor this type of issue.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1119779-2012-00020 |
| MDR Report Key | 2826318 |
| Report Source | 05 |
| Date Received | 2012-10-31 |
| Date of Report | 2012-10-16 |
| Date of Event | 2012-10-11 |
| Date Mfgr Received | 2012-10-16 |
| Date Added to Maude | 2012-11-13 |
| 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 | GAIL CLAIBORNE |
| 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 |
| Manufacturer Street | PERIF. LUIS DONALDO COLOSIO #579 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT |
| Product Code | JTX |
| Date Received | 2012-10-31 |
| 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 | 2012-10-31 |