MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-12-01 for BARD LH-0031 manufactured by Bard (becton, Dickinson & Co.).
[93721091]
When removing 20 gauge 0. 75 inch needle from port, the safety mechanism would not engage. It required a direct pull from port to separate it from the pt. Needle remained uncovered upon removal. Neither pt nor staff were harmed. Specific pt info (name/age) was not provided to staff filing this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073704 |
| MDR Report Key | 7078920 |
| Date Received | 2017-12-01 |
| Date of Report | 2017-11-28 |
| Date of Event | 2017-11-27 |
| Date Added to Maude | 2017-12-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BARD |
| Generic Name | NON-POWER HUBER NEEDLE |
| Product Code | PTI |
| Date Received | 2017-12-01 |
| Model Number | LH-0031 |
| Lot Number | ASBXS0040 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD (BECTON, DICKINSON & CO.) |
| Manufacturer Address | FRANKLIN LAKES NJ 07417 US 07417 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-12-01 |