MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2018-04-14 for HIGH FLOW INFUSION LINE FOR 20, 23, 25 & 27G CANNULA SYSTEM 1279.HF manufactured by Dutch Opthalmic Research Center Bv.
[106027187]
Irrigation tube there is a lint/dirt and cause infection, hence concluded as reportable. This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research centre (b)(4). ). Details of this activity were discussed with cdrh office of compliance (b)(6) during a tele-conference on (b)(6) 2017. All available information has been disclosed. This complaint has now been closed.
Patient Sequence No: 1, Text Type: N, H10
[106027188]
A report from (b)(6) has been received. The following has been reported: lint at the high infusion line - see film usb stick. All information has been disclosed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00074 |
| MDR Report Key | 7431563 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-04-14 |
| Date of Report | 2018-02-19 |
| Date of Event | 2018-02-19 |
| Date Mfgr Received | 2015-02-19 |
| Date Added to Maude | 2018-04-14 |
| 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 | KYG |
| Date Received | 2018-04-14 |
| Catalog Number | 1279.HF |
| Operator | PHYSICIAN |
| 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 | 2018-04-14 |