MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other,user facility report with the FDA on 2020-03-20 for BD VACUTAINER? SODIUM HEPARINN 158 USP UNITS BLOOD COLLECTION TUBES 367874 manufactured by Becton, Dickinson & Co. (broken Bow).
[186711697]
Date of event: unknown. The date received by manufacturer has been used for this field. 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
[186711698]
It was reported that underfill occurred during use with a bd vacutainer? Sodium heparin 158 usp units blood collection tubes. The following information was provided by the initial reporter, "the donor site confirmed that we have not had any other issues with lower volume blood collections using the vacutainer tubes, so this seems to be an isolated case that occurred with the edta tubes (perhaps a donor or technician issue). They have used the same batch of tubes for several other collections and there is nothing to suggest a problem with the tubes or lot. Please consider this issue closed and thanks again franca for the information on the expected variation in volumes collected, and what can affect this, it was very helpful. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2020-00306 |
| MDR Report Key | 9862420 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-20 |
| 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 | 3 |
| Brand Name | BD VACUTAINER? SODIUM HEPARINN 158 USP UNITS BLOOD COLLECTION TUBES |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | JKA |
| Date Received | 2020-03-20 |
| Model Number | 367874 |
| Catalog Number | 367874 |
| Lot Number | UNKNOWN |
| 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 | 2020-03-20 |