MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2019-01-17 for BD VACUTAINER? CPT? CELL PREPARATION TUBE WITH SODIUM HEPARIN 362753 manufactured by Becton, Dickinson & Co..
[133461548]
Date of event: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[133461549]
It was reported that the bd vacutainer? Cpt? Cell preparation tube with sodium heparin had erroneous results from a "10 fold decrease in yield" compared to the "tube processed with ficoll", resulting in a delay of treatment to the patient, who then had to be redrawn at a later, undisclosed date.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2019-00005 |
| MDR Report Key | 8257387 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2019-01-17 |
| Date of Report | 2019-07-31 |
| Date of Event | 2019-01-02 |
| Date Mfgr Received | 2019-01-02 |
| Device Manufacturer Date | 2018-08-01 |
| Date Added to Maude | 2019-01-17 |
| 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 | 3 |
| Brand Name | BD VACUTAINER? CPT? CELL PREPARATION TUBE WITH SODIUM HEPARIN |
| Generic Name | LYMPHOCYTE SEPARATION MEDIUM |
| Product Code | JCF |
| Date Received | 2019-01-17 |
| Catalog Number | 362753 |
| Lot Number | 8213831 |
| Device Expiration Date | 2019-08-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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. Required No Informationntervention | 2019-01-17 |