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 2020-03-31 for BD VACUTAINER? PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER 368658 manufactured by Becton, Dickinson & Co., (bd).
[188658557]
Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
Patient Sequence No: 1, Text Type: N, H10
[188658558]
It was reported during use the bd vacutainer? Push button blood collection set with pre-attached holder a needlestick injury-post use non patient needle separates from the holder luer/adaptor/hub. The following information was provided by the initial reporter: "nurse sustained a needlestick injury when the male luer separated from the plastic bottle container, exposing the rubber covered inner needle. Injury sustained when member of staff continued to attempt blood sampling with exposed needle. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1024879-2020-00239 |
| MDR Report Key | 9905736 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-03-11 |
| Date Added to Maude | 2020-03-31 |
| 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? PUSH BUTTON BLOOD COLLECTION SET WITH PRE-ATTACHED HOLDER |
| Generic Name | BLOOD SPECIMEN COLLECTION DEVICE |
| Product Code | FMI |
| Date Received | 2020-03-31 |
| Catalog Number | 368658 |
| Lot Number | UNKNOWN |
| 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 | 2020-03-31 |