MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2013-09-10 for ARCHITECT CYCLOSPORINE 01L75-55 manufactured by Abbott Laboratories.
[3808496]
The customer reported a splash in his eye while transferring the cyclosporine calibrator to the immunosuppressant tube. The tech washed the eye with water to treat some mild pain. No further treatment was administered. No impact to patient management or user safety was reported.
Patient Sequence No: 1, Text Type: D, B5
[11089764]
(b)(4). Product evaluation is in process and the results will be submitted in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[26383004]
The customer was splashed in the eye while using the architect cyclosporine calibrator and whole blood precipitation kit. The package inserts and material safety data sheets for the products were reviewed and sufficient labeling precautions are provided to prevent such an incident. A deficiency was not identified as no adverse or non-statistical trends were identified related to this issue. Based on the evaluation results, no malfunction was identified to be related to this issue.
Patient Sequence No: 1, Text Type: N, H10
[32348323]
Correction is added (common device name) and catalog #).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1415939-2013-00340 |
| MDR Report Key | 3339634 |
| Report Source | 01 |
| Date Received | 2013-09-10 |
| Date of Report | 2013-09-08 |
| Date Mfgr Received | 2013-12-12 |
| Date Added to Maude | 2013-11-18 |
| 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 | NOEMI ROMERO-KONDOS, RN BSN |
| Manufacturer Street | 100 ABBOTT PARK ROAD DEPT. 09B9, LCCP1-3 |
| Manufacturer City | ABBOTT PARK IL 600643537 |
| Manufacturer Country | US |
| Manufacturer Postal | 600643537 |
| Manufacturer Phone | 847937-512 |
| Manufacturer G1 | ABBOTT LABORATORIES |
| Manufacturer Street | 100 ABBOTT PARK ROAD |
| Manufacturer City | ABBOTT PARK IL 60064350 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60064 3500 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARCHITECT CYCLOSPORINE |
| Product Code | MKW |
| Date Received | 2013-09-10 |
| Catalog Number | 01L75-55 |
| Lot Number | UNKNOWN |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 100 ABBOTT PARK ROAD ABBOTT PARK IL 60064350 US 60064 3500 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-09-10 |