MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2016-04-15 for MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET N/A C-TCCS-600 manufactured by Cook Inc.
[42807105]
(b)(4). Event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[42807106]
A male patient of unknown age had a segmental resection of the right lower jaw. At post operative day 9, the physician had cleaned and replaced the melker catheter leaving the neck tape loose. When the nurse visited to the patient's room, she found unintended decannulation. The catheter came off when the patient was coughing, because the neck tape was loosely placed. There was no adverse effect to the patient reported.
Patient Sequence No: 1, Text Type: D, B5
[58620458]
(b)(4). Event evaluation - during the course of the investigation, a review of the complaint history, quality control, specifications, and instructions for use (ifu) of the product was conducted. The complaint device was not returned. Therefore, no physical examinations could be performed. However, a document based investigation evaluation was performed. There is no evidence to suggest the product was not made to specifications. The ifu provided with the set provides instructions as to the placement of the trach tape on the airway catheter. Based on the information provided the root cause has been determined to be user technique. We will continue to monitor for similar complaints. The appropriate internal personnel have been notified. Per the risk assessment, no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[58620459]
A male patient of unknown age had a segmental resection of the right lower jaw. At post operative day 9, the physician had cleaned and replaced the melker catheter leaving the neck tape loose. When the nurse visited to the patient's room, she found unintended decannulation. The catheter came off when the patient was coughing, because the neck tape was loosely placed. There was no adverse effect to the patient reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2016-00238 |
| MDR Report Key | 5581711 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2016-04-15 |
| Date of Report | 2016-03-28 |
| Date of Event | 2016-03-28 |
| Date Facility Aware | 2016-03-28 |
| Date Mfgr Received | 2016-03-28 |
| Date Added to Maude | 2016-04-15 |
| 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. RITA HARDEN |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET |
| Generic Name | BWC NEEDLE, EMERGENCY AIRWAY |
| Product Code | BWC |
| Date Received | 2016-04-15 |
| Model Number | N/A |
| Catalog Number | C-TCCS-600 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-04-15 |