MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-06 for ISPAN GAS TANK REGULATOR 8065797303 manufactured by Air Liquide.
[116538433]
No 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. The manufacturer internal reference number is: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[116538434]
A supply coordinator reported that an ophthalmic gas dispensing regulator valve was not working properly during corneal replacement surgery when it would not allow a sufficient supply of gas to be dispensed. An alternate regulator device was obtained in order to complete the procedure with approximately a twenty minute delay in procedure time. There was no impact to the patient.
Patient Sequence No: 1, Text Type: D, B5
[128297887]
Per the contract manufacturer, a review of the batch production record for the provided lot number showed no unusual manufacturing issues. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1610287-2018-00030 |
| MDR Report Key | 7754683 |
| Date Received | 2018-08-06 |
| Date of Report | 2018-12-19 |
| Date of Event | 2018-07-02 |
| Date Mfgr Received | 2018-12-05 |
| Device Manufacturer Date | 2017-04-26 |
| Date Added to Maude | 2018-08-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BRYAN BLAKE |
| Manufacturer Street | 6201 SOUTH FREEWAY MAIL STOP AB2-6 |
| Manufacturer City | FORT WORTH TX 76134 |
| Manufacturer Country | US |
| Manufacturer Postal | 76134 |
| Manufacturer Phone | 8176152230 |
| 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 GAS TANK REGULATOR |
| Generic Name | INTRAOCULAR GAS |
| Product Code | LPO |
| Date Received | 2018-08-06 |
| Returned To Mfg | 2018-09-27 |
| Model Number | NA |
| Catalog Number | 8065797303 |
| Lot Number | 711606 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | AIR LIQUIDE |
| Manufacturer Address | 13140 TI BLVD. DALLAS TX 75243 US 75243 |
| Brand Name | ISPAN GAS TANK REGULATOR |
| Generic Name | INTRAOCULAR GAS |
| Product Code | LPO |
| Date Received | 2018-08-06 |
| Returned To Mfg | 2018-09-27 |
| Model Number | NA |
| Catalog Number | 8065797303 |
| Lot Number | 711606 |
| 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 | 1. Other | 2018-08-06 |