MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-22 for BD ULTRASAFE? PLUS X100L PNG RFS. 47594130 manufactured by Becton Dickinson Hungary Kft (bd).
[143044938]
Date of event: 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
[143044939]
It was reported there were 200 occurrences where syringes were not able to be assembled correctly as the syringe did not drop into the safety device with a bd ultrasafe? Plus x100l png rfs. The following information was provided by the initial reporter: assembled 500 safety devices. Around 40 % of the syringes can`t be assembled in the standard way. These 40% of syringes did not drop into the safety device. Rather, they get hung up in the device before reaching the snaps. This syringes stick around 1 cm over. The syringe could be easily pushed with a finger completely in the safety device. But this is not the normal assembling process and not common for the clinical production, because we normally have a plunger rod already assembled in this assembling step. If you push the syringe in the safety device by finger you feel a scraping of the syringe in the safety device (area around the spring). During visual inspection afterwards you can`t see any damages or scratches.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009081593-2019-00135 |
| MDR Report Key | 8536565 |
| Date Received | 2019-04-22 |
| Date of Report | 2019-06-04 |
| Date of Event | 2019-04-01 |
| Date Mfgr Received | 2019-04-01 |
| Device Manufacturer Date | 2018-10-15 |
| Date Added to Maude | 2019-04-22 |
| 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 HUNGARY KFT (BD) |
| Manufacturer Street | UVEGGYAR UTCA 3 |
| Manufacturer City | KORNYE TATABANYA 2851 |
| Manufacturer Country | HU |
| Manufacturer Postal Code | 2851 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BD ULTRASAFE? PLUS X100L PNG RFS. |
| Generic Name | ANTISTICK SYRINGE |
| Product Code | MEG |
| Date Received | 2019-04-22 |
| Catalog Number | 47594130 |
| Lot Number | 8288952 |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON DICKINSON HUNGARY KFT (BD) |
| Manufacturer Address | UVEGGYAR UTCA 3 KORNYE TATABANYA 2851 HU 2851 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-22 |