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 2020-03-24 for BD VACUTAINER? K2 EDTA (K2E) 10.8 MG BLOOD COLLECTION TUBES 368661 manufactured by Becton, Dickinson & Co. (broken Bow).
[185208885]
"multiple lot numbers: there were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 9095813, medical device expiration date: 2020-09-30, device manufacture date: 2019-04-05, medical device lot #: 9280963, medical device expiration date: 2021-03-31, device manufacture date: 2019-10-07. " a sample is available for evaluation. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[185208886]
It was reported that foreign matter was discovered in the tubes prior to use with a bd vacutainer? K2 edta (k2e) 10. 8 mg blood collection tubes. The following information was provided by the initial reporter: it was reported that site found black spots in the tubes. How many tubes from each lot contained the black spots? Only one tube from lot#9280963 and over 50 from lot# 9095813, didn? T open all of the packs although the spots on a few tubes from each pack.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1917413-2020-00327 |
| MDR Report Key | 9871756 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-24 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-24 |
| 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) 10.8 MG BLOOD COLLECTION TUBES |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | JKA |
| Date Received | 2020-03-24 |
| Returned To Mfg | 2020-03-09 |
| Model Number | 368661 |
| Catalog Number | 368661 |
| Lot Number | SEE H.10 |
| 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 | 2020-03-24 |