MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-07-30 for ANTICOAGULANT CITRATE DEXTROSE SOLUTION, SOLUTION A, USP N/A 9350 manufactured by Citra Labs, Llc.
| Report Number | 0001216032-2019-00001 |
| MDR Report Key | 8843011 |
| Date Received | 2019-07-30 |
| Date of Report | 2019-07-25 |
| Date Mfgr Received | 2018-05-01 |
| Date Added to Maude | 2019-07-30 |
| 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 | MS. SHARI BAILEY |
| Manufacturer Street | 55 MESSINA DRIVE |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal | 02184 |
| Manufacturer Phone | 7818489386 |
| Manufacturer G1 | CITRA LABS, LLC |
| Manufacturer Street | 55 MESSINA DRIVE |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02184 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ANTICOAGULANT CITRATE DEXTROSE SOLUTION, SOLUTION A, USP |
| Generic Name | ACD-A |
| Product Code | KSB |
| Date Received | 2019-07-30 |
| Model Number | N/A |
| Catalog Number | 9350 |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CITRA LABS, LLC |
| Manufacturer Address | 55 MESSINA DRIVE BRAINTREE MA 02184 US 02184 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-07-30 |