MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-29 for BD MICROTAINER * 365973 manufactured by Becton Dickinson.
[3530125]
We received a shipment of the following microtainers: bd microtainer z (no additive tubes), bd microtainer tubes with k2e (k2edta), bd microtainer sst, bd microtainer pst tubes with lh. On our old shipments - ref #365963; 365973; 365967; 365985. There were expiration dates on the tubes. With the new shipment there are no expiration dates on the tubes. Device #1is this a laboratory device or laboratory test? Yes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3139457 |
| MDR Report Key | 3139457 |
| Date Received | 2013-05-29 |
| Date of Report | 2013-05-29 |
| Date of Event | 2013-05-29 |
| Report Date | 2013-05-29 |
| Date Reported to FDA | 2013-05-29 |
| Date Reported to Mfgr | 2013-05-31 |
| Date Added to Maude | 2013-05-31 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD MICROTAINER |
| Generic Name | TUBE, COLLECTION, CAPILLARY BLOOD |
| Product Code | GIO |
| Date Received | 2013-05-29 |
| Model Number | * |
| Catalog Number | 365973 |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON |
| Manufacturer Address | ONE BECTON DRIVE FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-29 |