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 2020-03-20 for NEEDLE ECLIPSE 23X1 RB 305762 manufactured by Becton Dickinson Medical (singapore).
[188220753]
Device expiration date: unknown. The reported lot# 9267472 was not found for the catalog number. Device manufacture date: unknown. Investigation summary: no photo/ sample were returned for investigation. Root cause could not be determined. The complaint will be re-opened and re-investigated if the sample is returned. Investigation conclusion: unable to confirm the customer experience as no photo/ sample was returned for investigation. Root cause description: no photo/ sample were returned for investigation. Root cause could not be determined.
Patient Sequence No: 1, Text Type: N, H10
[188220754]
It was reported that a safety mechanism failure occurred during use with a needle eclipse 23x1 rb. The following information was provided by the initial reporter, "the safety guard on the needle had broken when the nurse attempted to push the safety guard down over the needle, resulting in the stick. The plastic of the safety guard broke at the base of the needle where the guard hinges with the needle. " no medical intervention was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041187-2020-00158 |
| MDR Report Key | 9861834 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-02-26 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-20 |
| 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 MEDICAL (SINGAPORE) |
| Manufacturer Street | 30 TUAS AVENUE 2 |
| Manufacturer City | SINGAPORE |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEEDLE ECLIPSE 23X1 RB |
| Generic Name | HYPODERMIC SINGLE LUMEN NEEDLE |
| Product Code | FMI |
| Date Received | 2020-03-20 |
| Model Number | 305762 |
| Catalog Number | 305762 |
| Lot Number | SEE. H.10 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON MEDICAL (SINGAPORE) |
| Manufacturer Address | 30 TUAS AVENUE 2 SINGAPORE |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-03-20 |