MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-15 for ISPAN PERFLUOROPROPANE (C3F8) GAS 8065797102 manufactured by Air Liquide.
[133227550]
No gas tank sample has been received by manufacturing for evaluation. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available. Additional information has been requested. This is the second of two reports for this reported event. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[133227551]
A director of nurses reported that an ophthalmic gas and gas dispensing regulator valve were both used during a pars plana vitrectomy (ppv), membrane peel (mp) and internal limiting membrane (ilm) procedure. The instilled gas bubble was not successfully retained inside of the patient's eye. Additional information was requested and received. There was no impact to the patient and no additional treatment or intervention was required.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1610287-2019-00002 |
| MDR Report Key | 8248575 |
| Date Received | 2019-01-15 |
| Date of Report | 2019-03-13 |
| Date of Event | 2018-11-26 |
| Date Mfgr Received | 2019-03-04 |
| Device Manufacturer Date | 2017-09-13 |
| Date Added to Maude | 2019-01-15 |
| 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. CINDY MILAM |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152231 |
| Manufacturer G1 | AIR LIQUIDE |
| Manufacturer Street | 13140 TI BLVD. |
| Manufacturer City | DALLAS TX 75243 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 75243 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ISPAN PERFLUOROPROPANE (C3F8) GAS |
| Generic Name | INTRAOCULAR GAS |
| Product Code | LPO |
| Date Received | 2019-01-15 |
| Returned To Mfg | 2018-12-21 |
| Model Number | NA |
| Catalog Number | 8065797102 |
| Lot Number | 725611 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AIR LIQUIDE |
| Manufacturer Address | 13140 TI BLVD. DALLAS TX 75243 US 75243 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-15 |