MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-07 for BD VACUTAINER? CPT? CELL PREPARATION TUBE WITH SODIUM CITRATE 362761 manufactured by Becton, Dickinson & Co..
[132348206]
Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
Patient Sequence No: 1, Text Type: N, H10
[132348207]
It was reported that there were thought to be "irregular amounts of sodium citrate" in the bd vacutainer? Cpt? Cell preparation tubes with sodium citrate that led to erroneous results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2018-04111 |
| MDR Report Key | 8224223 |
| Date Received | 2019-01-07 |
| Date of Report | 2019-02-13 |
| Date of Event | 2018-12-18 |
| Date Mfgr Received | 2018-12-18 |
| Date Added to Maude | 2019-01-07 |
| 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 | 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 | BECTON, DICKINSON & CO. |
| Manufacturer Street | 150 SOUTH 1ST AVENUE |
| Manufacturer City | BROKEN BOW NE 68822 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68822 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD VACUTAINER? CPT? CELL PREPARATION TUBE WITH SODIUM CITRATE |
| Generic Name | LYMPHOCYTE SEPARATION MEDIUM |
| Product Code | JCF |
| Date Received | 2019-01-07 |
| Catalog Number | 362761 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-01-07 |