MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-05-25 for ANTICOAGULANT CITRATE DEXTROSE SOLUTION, SOLUTION A (ACD-A), USP, 30 ML N/A PN9332 manufactured by Citra Labs, Llc.
[2639926]
A female technician was drawing up (with a syringe) to put 3ml's of acd-a, 30ml solution in preparation before a patient entered the room and air was in the syringe. As the technician tried to remove the air, the solution discharged in an "arc" motion into her eyes, mainly her right eye. She wears contacts. Location of event: hospital operating room. Patient reaction/immediate care: eyes were red and she experienced irritation burning/itchiness. The help nurse immediately flushed the technician's eyes with water for 10 - 12 minutes; however, eyes were still red. The technician went to the er to seek further evaluation and the physician from the er flushed her eyes with water again for 5 minutes. The technician's eye irritation went away and the redness lasted until the next day, (b)(6) 2012. The physician advised the technician not to wear her contacts for the next 24 hours and discharged her back to full duty. This is a component in a biomet kit. Item: 800-0505a, description: gps lll mini kit w/30ml acd-a, device code: kss, lot# 112904.
Patient Sequence No: 1, Text Type: D, B5
[9929318]
Reference; mdr number: 1825034-2012-00683.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 0001216032-2012-00001 |
| MDR Report Key | 2589120 |
| Report Source | 05 |
| Date Received | 2012-05-25 |
| Date of Report | 2012-05-10 |
| Date of Event | 2012-05-10 |
| Date Mfgr Received | 2012-05-10 |
| Device Manufacturer Date | 2011-04-29 |
| Date Added to Maude | 2012-05-29 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR DAVID LINO |
| Manufacturer Street | 55 MESSINA DRIVE |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal | 02184 |
| Manufacturer Phone | 7818482174 |
| 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 | 3 |
| Brand Name | ANTICOAGULANT CITRATE DEXTROSE SOLUTION, SOLUTION A (ACD-A), USP, 30 ML |
| Generic Name | N/A |
| Product Code | LYZ |
| Date Received | 2012-05-25 |
| Model Number | N/A |
| Catalog Number | PN9332 |
| Lot Number | D19H |
| ID Number | N/A |
| Device Expiration Date | 2014-09-30 |
| 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. Required No Informationntervention | 2012-05-25 |