MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-16 for REN? GEL, 1.5CC 08-015-00-V04 manufactured by Cytophil, Inc..
[90461559]
A review of the device history records did not reveal any irregularities or issues with syringe. Cytophil received the complaint device for evaluation. The device was evaluated "as received" under 50x magnification. It was then carefully rinsed and viewed again under 50x magnification. There was no visible defect viewed under magnification. The syringe was then filled with water as a worst case test, a closed stopcock was attached to the luer end, and the syringe was tested under pressure, with no leakage occurring. The device performed according to specification. In an attempt to recreate the reported event, cytophil then backed the stopcock off the luer connection, and was able to reproduce a minor drip/leakage at the hub/luer. This implies an issue with either the needle hub, or that the needle may not have been fully engaged or seated within the luer connection. Cytophil did not receive the needle for evaluation. However, as the user stated, the same needle was used with both the complaint device, and then with the second renu gel device, with no reported issues. With regard to the complainant's observation that there was moisture in the pouch, this is a normal event. The renu gel device is sterilized using steam and pressure, which requires that a small amount of water be injected inside the foil pouch prior to sterilization. The renu gel instructions for use explains that the moisture is an essential part of the sterilization cycle, that the residual moisture is a normal expected occurrence and is not an indication of a defective product. The results of cytophil's complaint investigation are inconclusive. Cytophil was unable to confirm the reported complaint, or to definitively identify a root cause of the reported event. A review of cytophil's complaint history for the past 24 months indicates one similar complaint. The complaint is being closed, and will be tracked.
Patient Sequence No: 1, Text Type: N, H10
[90461560]
The ent surgery center reported that when they opened a renu gel device during a case, the device "seemed to be broken inside the aluminum package. When the nurse opened it onto the field, he noticed the inside of the package was wet and dripping. " the physician then attempted to use the device but was unsuccessful in using the device. It was reported that the renu gel leaked out the sides where the syringe attached to the needle. There was a second renu gel device in the procedure room which was used to successfully complete the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007225376-2017-00005 |
| MDR Report Key | 6952826 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-16 |
| Date of Report | 2017-10-16 |
| Date of Event | 2017-09-18 |
| Date Mfgr Received | 2017-09-18 |
| Device Manufacturer Date | 2017-06-21 |
| Date Added to Maude | 2017-10-16 |
| 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 | MRS. KRISTIE SOTO |
| Manufacturer Street | 2485 CORPORATE CIRCLE SUITE 2 |
| Manufacturer City | EAST TROY WI 53120 |
| Manufacturer Country | US |
| Manufacturer Postal | 53120 |
| Manufacturer Phone | 2626422765 |
| Manufacturer G1 | CYTOPHIL, INC. |
| Manufacturer Street | 2485 CORPORATE CIRCLE SUITE 2 |
| Manufacturer City | EAST TROY WI 53120 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53120 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REN? GEL, 1.5CC |
| Generic Name | SYSTEM, VOCAL CORD MEDIALIZATION |
| Product Code | MIX |
| Date Received | 2017-10-16 |
| Returned To Mfg | 2017-09-22 |
| Model Number | 08-015-00-V04 |
| Lot Number | S708-00035 |
| Device Expiration Date | 2019-06-21 |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CYTOPHIL, INC. |
| Manufacturer Address | 2485 CORPORATE CIRCLE SUITE 2 EAST TROY WI 53120 US 53120 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-16 |