MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-21 for DISPOSABLE UNIVERSAL SILICONE INFUSION LINE FOR 23 GAUGE / 0.6 MM CANNULA SYSTEM 1279.IA manufactured by D.o.r.c Dutch Ophthalmic International Bv.
[103551350]
This reportable event was identified during a voluntary retrospective review of all complaints since 2015 by the manufacturer (dutch ophthalmic research (b)(4)). Details of this activity were discussed with cdrh office of compliance ((b)(6)) during a tele-conference on (b)(6) 2017. Assuming worst case during surgery, no irrigation or less irrigation may lead to hypotony therefore is deemed as reportable. No sample was returned, therefore unable to confirm this complaint. All available information has been provided. This complaint has now been closed.
Patient Sequence No: 1, Text Type: N, H10
[103551351]
A report has been received from an event that occurred in (b)(6). The following has been reported: " no or minimal irrigation from the infusion line during surgery. During priming there was normal irritation. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00048 |
| MDR Report Key | 7359485 |
| Date Received | 2018-03-21 |
| Date of Report | 2015-01-15 |
| Date of Event | 2015-01-15 |
| Date Mfgr Received | 2018-01-15 |
| Date Added to Maude | 2018-03-21 |
| 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 |
| Manufacturer City | EXETER NH 03833 |
| Manufacturer Country | US |
| Manufacturer Postal | 03833 |
| Manufacturer Phone | 6037538824 |
| Manufacturer G1 | D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV |
| Manufacturer Street | SCHEIJDELVEWEG 2 |
| Manufacturer City | ZUIDLAND, NETHERLANDS |
| Manufacturer Country | NL |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | DISPOSABLE UNIVERSAL SILICONE INFUSION LINE FOR 23 GAUGE / 0.6 MM CANNULA SYSTEM |
| Generic Name | DISPOSABLE UNIVERSAL SILICONE INFUSION LINE FOR 23 GAUGE / 0.6 MM CANNULA SYSTEM |
| Product Code | KYG |
| Date Received | 2018-03-21 |
| Catalog Number | 1279.IA |
| Lot Number | 2000355594 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | D.O.R.C DUTCH OPHTHALMIC INTERNATIONAL BV |
| Manufacturer Address | SCHEIJDELVEWEG 2 ZUIDLAND, NETHERLANDS NL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-03-21 |