MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-20 for NEO-FIT NEONATAL ENDOTRAC 42-2540 manufactured by Coopersurgical, Inc..
[103283567]
(b)(4). Investigation *analysis and findings the reported event of the ett sliding through the neo-fit device cannot be verified as the affected device was discarded and will not be returned. However, if the device is returned in the future and made available for evaluation, the complaint may be reopened and addressed as needed. Review of the two-year complaint history indicated this to be the only reported event from the affected reported lot and indicates it to be an isolated case. Inventory reviews of the affected lot indicated that all inventory had been depleted and not available for further review. This was the case for the lot that was built prior to 219772 and the one that followed. In all three cases, the lot dhr's were reviewed and no abnormalities were found. In addition, the manufacturing line and associated components were reviewed and evaluated and noted that nothing had been altered and was found in an acceptable stable state. The manufacturing method sheet instructions were also reviewed and were found acceptable without any alteration. In evaluating finished goods product from various lots, product found to be acceptable based on all manufacturing acceptance criteria. In conclusion, the root cause for the reported event is considered indeterminable due to multiple factors previously stated, including and most importantly, the absence of the actual affected device. Corrective actions *correction and/or corrective action corrective action is not applicable at this time due to the absence of the affected device, inventory depletion and manufacturing controls and practices found in an acceptable and stable state. Reason: per (b)(4), this complaint will be monitored for trending. The feasibility of possible future product components and or manufacturing process will be evaluated. However, based on current design, it is recommended that it be evaluated by sustaining engineering. *was the complaint confirmed? No.
Patient Sequence No: 1, Text Type: N, H10
[103283568]
The concern: (b)(6) 2018 - the ett was secured to the upper lip using the neo-fit device. Patient repositioned with slight move in head to the right side. The ventilator started to alarm and the ett was noted to have slid through the neo-fit device 2 cm and the ett was no longer in the trachea. 4 attempts required to re-intubate the patient, during which, the patient had episodes of severe tachycardia and bradycardia. Secured new device with tape. The site reports experiencing several instances where the "bridge" portion of the device is securely attached to the face, yet the ett freely slides through the white velcro, resulting in extubation. The "little metal teeth" on the white velcro strap meant to keep the tube secure do not appear to work. The sample was not retained.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1216677-2018-00005 |
| MDR Report Key | 7355133 |
| Date Received | 2018-03-20 |
| Date of Report | 2018-03-20 |
| Date of Event | 2018-02-10 |
| Date Mfgr Received | 2018-02-20 |
| Device Manufacturer Date | 2017-03-30 |
| Date Added to Maude | 2018-03-20 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. NANA BANAFO |
| Manufacturer Street | 75 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal | 06611 |
| Manufacturer Phone | 2036015200 |
| Manufacturer G1 | COOPERSURGICAL, INC. |
| Manufacturer Street | 75 CORPORATE DR |
| Manufacturer City | TRUMBULL CT 06611 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 06611 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEO-FIT NEONATAL ENDOTRAC |
| Generic Name | NEO-FIT NEONATAL ENDOTRAC |
| Product Code | JAY |
| Date Received | 2018-03-20 |
| Model Number | 42-2540 |
| Catalog Number | 42-2540 |
| Lot Number | 219772 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOPERSURGICAL, INC. |
| Manufacturer Address | 75 CORPORATE DR TRUMBULL CT 06611 US 06611 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-03-20 |