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 2020-03-23 for BD VACUTAINER? ECLIPSE? BLOOD COLLECTION NEEDLE 368607 manufactured by Becton, Dickinson & Co., (bd).
[188656813]
Date of event: unknown. The date received by manufacturer has been used for this field. Device expiration date: unknown. Device manufacture date: unknown. 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
[188656814]
It was reported that a needle stick injury occurred during use with a bd vacutainer? Eclipse? Blood collection needle. The following information was provided by the initial reporter, "it was reported that the safety shield comes off and there also was a needle stick. Per email: good afternoon. They had an issue with the eclipse needle # 368607- 21 gauge x 1. 25 (black). A while back, she had several in which the pink guard came off and became unattached. In january, one of their phlebotomist was accidently stuck. She apologized for not informing me of this incident. In addition, we discussed that the safety lok sheath must closed until you hear it click. I did some reeducation and provided wall charts for them. (safety lok) they did not have specific lot#s for the eclipse, but i am going to get them a case of product. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1024879-2020-00214 |
| MDR Report Key | 9866563 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-03-03 |
| Date Mfgr Received | 2020-03-03 |
| Date Added to Maude | 2020-03-23 |
| 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., (BD) |
| Manufacturer Street | 1575 AIRPORT ROAD |
| Manufacturer City | SUMTER SC 29153 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 29153 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD VACUTAINER? ECLIPSE? BLOOD COLLECTION NEEDLE |
| Generic Name | HYPODERMIC SINGLE LUMEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-23 |
| Model Number | 368607 |
| Catalog Number | 368607 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO., (BD) |
| Manufacturer Address | 1575 AIRPORT ROAD SUMTER SC 29153 US 29153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-23 |