MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-11-09 for MELKER EMERGENCY CRICOTHYROTOMY CATHETER SET N/A C-TCCS-400 manufactured by Cook Inc.
[59563679]
(b)(4). The event is currently under investigation.
Patient Sequence No: 1, Text Type: N, H10
[59563680]
It was reported while performing a procedure the blade of the catheter set broke. Additional information has been requested as of the date of this report no other information is available.
Patient Sequence No: 1, Text Type: D, B5
[79153837]
Investigation? Evaluation. A review of the complaint history, device history record, instruction for use (ifu), manufacturing instructions, quality control, specifications, and trends of the device was conducted during the investigation. 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. A review of the device history record shows no nonconforming events which could contribute to this failure mode. It should be noted there were no other reported complaints for this lot number. Based on the information provided, no product returned and the results of our investigation, a definitive root cause could not be determined. We will continue to monitor for similar complaints. Per the quality engineering risk assessment no further action is required.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1820334-2016-01254 |
| MDR Report Key | 6089618 |
| Report Source | USER FACILITY |
| Date Received | 2016-11-09 |
| Date of Report | 2017-05-15 |
| Date Mfgr Received | 2017-05-08 |
| Device Manufacturer Date | 2014-11-26 |
| Date Added to Maude | 2016-11-09 |
| 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 | 2016-11-09 |
| Model Number | N/A |
| Catalog Number | C-TCCS-400 |
| 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 | 2016-11-09 |