MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-21 for BACKFLUSH INSTRUMENT WITH DIATHERMY, INCL. ACTIVE ASPIRATION. (23 GAUGE / 0.6 MM 1281.BTD05 manufactured by Dutch Opthalmic Research Center Bv.
[109512404]
There is foreign material attached on the shaft part. The investigation showed that the foreign object on the shaft is glue. This will be reviewed with the production department to find out how this has escaped the attention of the quality control. During the retrospective review, and as per the complaint description, foreign material may lead to serious harm to patient, 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. No information reasonably suggests anyone was harmed. All available information has been disclosed. This complaint has now been closed.
Patient Sequence No: 1, Text Type: N, H10
[109512405]
There is foreign material attached on the shaft part. No report of injury. All information has been disclosed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1222074-2018-00141 |
| MDR Report Key | 7531331 |
| Date Received | 2018-05-21 |
| Date of Report | 2015-11-30 |
| Date of Event | 2015-11-30 |
| Date Mfgr Received | 2015-11-30 |
| Date Added to Maude | 2018-05-21 |
| 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 |
| 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 | 0 |
| Brand Name | BACKFLUSH INSTRUMENT WITH DIATHERMY, INCL. ACTIVE ASPIRATION. (23 GAUGE / 0.6 MM |
| Generic Name | BACKFLUSH INSTRUMENT WITH DIATHERMY, INCL. ACTIVE ASPIRATION. (23 GAUGE / 0.6 MM |
| Product Code | HQR |
| Date Received | 2018-05-21 |
| Catalog Number | 1281.BTD05 |
| Lot Number | 2000371247 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-05-21 |