MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-14 for STYLET NEONATAL, FOR ETT SIZES 2.5 - 4 S5000N manufactured by Vyaire Medical, Inc.
[91969149]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[91969150]
Customer reported the following: "the covering on the stylet separated from the metal insert and had the potential to fall apart causing a choking hazard". "yes this product was used on a patient. The issue was detected after removing the stylet from the patients endotracheal tube. After noticing the separation of the tip from the end of the stylet. The endotracheal tube was removed, inspected and a new endotracheal tube was reinserted".
Patient Sequence No: 1, Text Type: D, B5
[109276336]
Device evaluation: two opened samples were received for further evaluation. Sample one was the device used during the reported incident. Sample two was a stock sample from the customer. Both samples were visually inspected. Sample one stress marks were observed on the sheath of the stylet and the sheath was split as reported. Therefore, the failure was confirmed. Sample two did not present any damage. In addition, vyaire took 5 random samples from the manufacturing line for further evaluation. No visual defects were found on the 5 samples. A thorough review of the entire manufacturing process was performed. The sheath is sealed from one side using a fixture. After this the plug is inserted into the sheath followed by the wire. At this time, the other side of the sheath is sealed using the same fixture. No issues were found during this operation. Sealing was performed correctly on the provided two samples. Sample one the slit occurred 1 inch before the sealing mark; therefore, this step in the manufacturing process has been ruled out. The next step in the manufacturing process, the stylet is bent on the opposite side of the plug. This is also done using a fixture. Since the split reported by the customer was on the plug side this operation is not considered to provoke the defect reported. In the final stage of the assembly process the stylet is cleaned with alcohol and placed inside the package. The packaging sealing machine has a fixture, this fixture has safe guards to prevent damage to the internal product during package sealing. The quality department then performs an inspection by sampling plan, per the procedure. This includes visual inspection to detect any defect cosmetic, or an incorrect assembly. The manufacturing equipment was also evaluated looking for any sharp edges that could have caused a cut in the sheath. The molding, bending, and packing fixtures, had no sharp edges, all equipment was found in proper working order. According to the investigation findings no issues were found at the manufacturing plant that could cause the reported defect. It is possible that the stress marks that were found in the sheath could be provoked by an excessive pull force. The root cause for this failure is undetermined. At this time vyaire has notified the assembly and quality personnel of this complaint failure. No other preventative or corrective actions will be implemented at this time. Vyaire will continue to track and trend for this type of failure.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030673-2017-00380 |
| MDR Report Key | 7030053 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-14 |
| Date of Report | 2018-02-22 |
| Date of Event | 2017-10-25 |
| Date Mfgr Received | 2017-10-25 |
| Date Added to Maude | 2017-11-14 |
| 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 | MINDY FABER |
| Manufacturer Street | 26125 NORTH RIVERWOODS BLVD |
| Manufacturer City | METTAWA IL 60045 |
| Manufacturer Country | US |
| Manufacturer Postal | 60045 |
| Manufacturer G1 | VYAIRE MEDICAL, INC |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION NO. 85 PARQUE INDUSTRIAL |
| Manufacturer City | MEXICALI BAJA CALIFORNIA NORTE |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STYLET NEONATAL, FOR ETT SIZES 2.5 - 4 |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2017-11-14 |
| Returned To Mfg | 2018-01-12 |
| Catalog Number | S5000N |
| Lot Number | 0001124216 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL, INC |
| Manufacturer Address | CERRADA VIA DE LA PRODUCCION NO. 85 PARQUE INDUSTRIAL MEXICALI BAJA CALIFORNIA NORTE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-11-14 |