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 2020-03-19 for BD VACUTAINER? BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES 363083 manufactured by Becton, Dickinson & Co. (broken Bow).
[186300312]
Date of event: unknown. The date received by manufacturer has been used for this field. (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
[186300313]
It was reported that underfill occurred during use with a bd vacutainer? Buffered sodium citrate (9nc) blood collection tubes. The following information was provided by the initial reporter, "there is no sample available. There is about 3/4 defective units noticed per day. The customer reports that about 20% of the tubes are affected. The filling level is about 85% of the volume. The laboratory decided to discard the tubes when the partial filling level is detected. The customer reports that was possible to collect blood sample successfully using the same lot. The defect is not being noticed in a particular department/shift/person etc. The customer use holder to transfer the blood to the tube. The tubes was not exposed to heat. " 200 occurrences were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2020-00301 |
| MDR Report Key | 9856326 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2019-06-07 |
| Date Added to Maude | 2020-03-19 |
| 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? BUFFERED SODIUM CITRATE (9NC) BLOOD COLLECTION TUBES |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | JKA |
| Date Received | 2020-03-19 |
| Model Number | 363083 |
| Catalog Number | 363083 |
| Lot Number | 9158817 |
| Device Expiration Date | 2020-03-31 |
| Device Availability | * |
| 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 | 2020-03-19 |