MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-07-09 for HIGH FLOW INFUSION LINE FOR 20, 23, 25 & 27G CANNULA SYSTEM 1279.HF manufactured by Dutch Opthalmic Research Center Bv.
[113425587]
This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre b. V. ). Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6) 2018. Incident caused harm to the patient, hence it is reportable all available information has been disclosed. This complaint has now been closed.
Patient Sequence No: 1, Text Type: N, H10
[113425588]
During surgery the eye collapsed. Perhaps there is something wrong with the gravity input set in cartridges.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00232 |
| MDR Report Key | 7669803 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-07-09 |
| Date of Report | 2017-03-10 |
| Date of Event | 2017-03-10 |
| Date Mfgr Received | 2017-03-10 |
| Date Added to Maude | 2018-07-09 |
| 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 LAURA SMITH |
| Manufacturer Street | 10 CONTINENTAL DR BLDG 1 |
| Manufacturer City | EXETER NH 03833 |
| Manufacturer Country | US |
| Manufacturer Postal | 03833 |
| Manufacturer Phone | 6037786929 |
| Manufacturer G1 | DUTCH OPTHALMIC RESEARCH CENTER BV |
| Manufacturer Street | SCHEIJDELVEWEG 2 |
| Manufacturer City | ZUIDLAND, 3214VN |
| Manufacturer Country | NL |
| Manufacturer Postal Code | 3214VN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH FLOW INFUSION LINE FOR 20, 23, 25 & 27G CANNULA SYSTEM |
| Generic Name | HIGH FLOW INFUSION LINE FOR 20, 23, 25 & 27G CANNULA SYSTEM |
| Product Code | NGY |
| Date Received | 2018-07-09 |
| Catalog Number | 1279.HF |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DUTCH OPTHALMIC RESEARCH CENTER BV |
| Manufacturer Address | SCHEIJDELVEWEG 2 ZUIDLAND, 3214VN NL 3214VN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-09 |