MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-01 for BD VACUTAINER? CPT? NH: ~130 IU FICOLL?: 2.0ML 362780 manufactured by Becton, Dickinson & Co. (broken Bow).
[140924709]
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter phone# (b)(6). Initial reporter e-mail: (b)(6). 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
[140924710]
It was reported that the bd vacutainer? Cpt? Nh: ~130 iu ficoll? : 2. 0ml experienced clotting. The following information was provided by the customer: i used the tubes that you sent me for experiments before christmas, and for experiments just two weeks ago, but today, i have had the same issue as with the previous lot of tubes, where the red blood cells won't go through the filter. This is extremely frustrating as the blood is very valuable. The tubes are due to expire on the 31st of this month, and have been kept at room temperature as required, and worked just two weeks ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2019-01083 |
| MDR Report Key | 8470383 |
| Date Received | 2019-04-01 |
| Date of Report | 2019-05-28 |
| Date of Event | 2019-03-15 |
| Date Mfgr Received | 2019-03-15 |
| Device Manufacturer Date | 2018-02-28 |
| Date Added to Maude | 2019-04-01 |
| 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 | 8015652341 |
| Manufacturer G1 | BECTON, DICKINSON & CO. (BROKEN BOW) |
| 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? NH: ~130 IU FICOLL?: 2.0ML |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | JCF |
| Date Received | 2019-04-01 |
| Catalog Number | 362780 |
| Lot Number | 8059582 |
| Device Expiration Date | 2019-03-31 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. (BROKEN BOW) |
| Manufacturer Address | 150 SOUTH 1ST AVENUE BROKEN BOW NE 68822 US 68822 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-01 |