MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-02-28 for CATHETER SUCT DRY RIGID 08FR KIT 100/CS 44-08 manufactured by Vyaire Medical..
[184690034]
Vyaire medical performed a failure investigation and according to the investigation, it is considered that manufacturing personnel contributed to the reported defect due to if hair mesh and ninja hat are not properly used inside manufacturing areas, a hair contamination could occur. Any additional information received from the customer will be included in a follow-up report.
Patient Sequence No: 1, Text Type: N, H10
[184690035]
The customer reported that they found a hair inside the sterile packaging of 8f suction catheter. The issue occur during preparation for suctioning of endotracheal tube
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030673-2020-00082 |
| MDR Report Key | 9771922 |
| Report Source | OTHER |
| Date Received | 2020-02-28 |
| Date of Report | 2019-10-08 |
| Date of Event | 2019-10-08 |
| Date Mfgr Received | 2019-10-08 |
| Device Manufacturer Date | 2019-02-27 |
| Date Added to Maude | 2020-02-28 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MINDY FABER |
| Manufacturer Street | 26125 N. RIVERWOODS BLVD. |
| Manufacturer City | METTAWA, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 7570116 |
| Manufacturer G1 | PRODUCTOS UROLOGOS DE MEXICO S.A. DE C.V. |
| Manufacturer Street | CERRADA VIA DE LA PRODUCCION85 PARQUE UNDUSTRIAL MEXICALI III |
| Manufacturer City | MEXICALI, 21397 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21397 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATHETER SUCT DRY RIGID 08FR KIT 100/CS |
| Generic Name | CATHETERS, SUCTION, TRACHEOBRONCHIAL |
| Product Code | BSY |
| Date Received | 2020-02-28 |
| Model Number | CATHETER SUCT DRY RIGID 08FR KIT 100/CS |
| Catalog Number | 44-08 |
| Lot Number | 004083203 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VYAIRE MEDICAL. |
| Manufacturer Address | 26125 N. RIVERWOODS BLVD. METTAWA, IL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |