MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-08-23 for CROSSTEX SYRINGE SLEEVES BCSSA manufactured by Crosstex International Inc..
| Report Number | 2433773-2019-00004 |
| MDR Report Key | 8926671 |
| Report Source | USER FACILITY |
| Date Received | 2019-08-23 |
| Date of Report | 2019-08-23 |
| Date of Event | 2019-07-24 |
| Date Mfgr Received | 2019-07-24 |
| Date Added to Maude | 2019-08-23 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANN MOUA |
| Manufacturer Street | 10 RANICK ROAD |
| Manufacturer City | HAUPPAUGE NY 22788 |
| Manufacturer Country | US |
| Manufacturer Postal | 22788 |
| Manufacturer Phone | 7633182956 |
| Manufacturer G1 | CROSSTEX INTERNATIONAL INC. |
| Manufacturer Street | 10 RANICK ROAD |
| Manufacturer City | HAUPPAUGE NY 22788 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 22788 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CROSSTEX SYRINGE SLEEVES |
| Generic Name | SYRINGE SLEEVES |
| Product Code | NRU |
| Date Received | 2019-08-23 |
| Returned To Mfg | 2019-07-30 |
| Model Number | BCSSA |
| Lot Number | 21006813-01 |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CROSSTEX INTERNATIONAL INC. |
| Manufacturer Address | 10 RANICK RD HAUPPAUGE NY 22788 US 22788 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-08-23 |