MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-02-24 for BD SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB 305950 manufactured by Bd Medical - Diabetes Care.
[184089264]
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[184089265]
It was reported bd syringe alrg sftygld 1ml w/ndl 27x1/2 rb had foreign matter on the inside of the syringe found prior to use. The following information was provided by the initial reporter: verbatim:? It was reported that the appeared the melted plastic was on the inside of the syringe barrel. Technical complaint received from the market. Syringe presented as it seemed melted plastic on the inside. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1920898-2020-00163 |
| MDR Report Key | 9745708 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-02-24 |
| Date of Report | 2020-03-06 |
| Date of Event | 2019-01-15 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2017-06-20 |
| Date Added to Maude | 2020-02-24 |
| 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 | BD MEDICAL - DIABETES CARE |
| Manufacturer Street | 1329 WEST HIGHWAY 6 |
| Manufacturer City | HOLDREGE NE 68949 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 68949 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB |
| Generic Name | PISTON SYRINGE |
| Product Code | MEG |
| Date Received | 2020-02-24 |
| Returned To Mfg | 2020-02-21 |
| Model Number | 305950 |
| Catalog Number | 305950 |
| Lot Number | 7171631 |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD MEDICAL - DIABETES CARE |
| Manufacturer Address | 1329 WEST HIGHWAY 6 HOLDREGE NE 68949 US 68949 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-24 |