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 2020-03-19 for SYRINGE 10ML LL 21X1IN TW INDIA 303064 manufactured by Becton Dickinson Medical (singapore).
[186718439]
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
[186718440]
It was reported that syringe 10ml ll 21x1in tw india had foreign matter inside the syringe. This occurred on 5 occasions during use. The following information was provided by the initial reporter: dust particles inside the syringes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8041187-2020-00156 |
| MDR Report Key | 9856659 |
| Report Source | FOREIGN,OTHER,USER FACILITY |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-04 |
| Date of Event | 2020-02-28 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2018-12-26 |
| Date Added to Maude | 2020-03-19 |
| 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 | SYRINGE 10ML LL 21X1IN TW INDIA |
| Generic Name | SYRINGE |
| Product Code | FMF |
| Date Received | 2020-03-19 |
| Catalog Number | 303064 |
| Lot Number | 8360505 |
| Device Availability | * |
| 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 | 2020-03-19 |