MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-06-25 for HIGH FLOW INFUSION LINE FOR 20, 23, 25 & 27G CANNULA SYSTEM 1279.HF manufactured by Dutch Opthalmic Research Center Bv.
[112307176]
This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer ((b)(6)). Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6). Sudden disengagement of infusion line during surgeries can lead to hypotony, hence considered as reportable. There is no information if a sample was available. Please note: this device is part of a pack 8310. 25k01 with lot 2000379541 all available information has been disclosed. This complaint has now been closed.
Patient Sequence No: 1, Text Type: N, H10
[112307177]
Our customer claims the following problem with our high flow infusion line 1279. Hf, which slips off several times during surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00203 |
| MDR Report Key | 7634907 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-06-25 |
| Date of Report | 2016-09-28 |
| Date of Event | 2016-09-28 |
| Date Mfgr Received | 2016-09-28 |
| Date Added to Maude | 2018-06-25 |
| 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 |
| Reporter Occupation | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| 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 | 2018-06-25 |
| Catalog Number | 1279.HF |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| 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 | 2018-06-25 |