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 2020-03-03 for BD VACUTAINER? K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES 367859 manufactured by Becton, Dickinson & Co. (broken Bow).
[187034467]
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[187034468]
It was reported that bd vacutainer? K2 edta (k2e) 5. 4 mg blood collection tubes contained foreign matter. The following information was provided by the initial reporter: "black spot in tube. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2020-00227 |
| MDR Report Key | 9782675 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-03 |
| Date of Report | 2020-02-10 |
| Date of Event | 2020-02-04 |
| Date Mfgr Received | 2020-02-10 |
| Device Manufacturer Date | 2019-07-03 |
| Date Added to Maude | 2020-03-03 |
| 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? K2 EDTA (K2E) 5.4 MG BLOOD COLLECTION TUBES |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | GIM |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2020-02-28 |
| Model Number | 367859 |
| Catalog Number | 367859 |
| Lot Number | 9184926 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-03 |