MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2018-11-28 for UNKNOWN manufactured by Cook Inc.
[128786637]
Cook airway exchange catheter with rapifit adapter 14 french. Catalog number: not provided, lot number: not provided. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
Patient Sequence No: 1, Text Type: N, H10
[128786638]
Medwatch report mw (b)(4) received on (b)(6) 2018 reported an event involving a broken tracheostomy reported on manufacturer report 1820334-2018-03193. The following information was received on (b)(6) 2018. Additional information was provided by the customer on (b)(6) 2018. The patient was admitted into the hospital (b)(6) 2018 after having been found unresponsive with emesis and incontinence of urine. Blood was noted in left nostril. The patient was diagnosed with large right basal ganglia intracerebral hemorrhage with some intraventricular extension and midline shift. The patient was positive for methamphetamines and diagnosed with malignant hypertension. The patient had a prior pontine stroke due to methamphetamine use resulting in residual right side weakness. The patient? S sputum was determined to be positive for beta (? )-haemolytic streptococci. On (b)(6) 2018 the patient continued to have cerebral edema with transfalcine herniation that required a right craniotomy for evacuation of the intracranial hemorrhage (ich). The patient was placed on a ventilator. On (b)(6) 2018, the patient had a percutaneous tracheostomy placed bedside with bronchoscopy. On (b)(6) 2018, the patient was placed on a t-piece with ventilation standby. The patient was continually attached to the ballard t-piece suction due to increased thick secretions. The tracheostomy sutures were removed (b)(6) 2018. On (b)(6) 2018, the patient was placed in the step down unit. On (b)(6) 2018, the patient experienced decreased mental status throughout the shift, as well as decreased blood pressure, increased temperature and increased trach secretions. The sputum culture revealed gram negative rods and the patient was started on metaneb. On (b)(6) 2018, staff noted pink, frothy secretions that continued through (b)(6) 2018. On (b)(6) 2018 the tracheal flange was noted to be broken and a new shiley #8 was placed using a cook airway exchange catheter with rapifit adapter 14 french. As reported, trach care was done twice daily and prn. In this event the cook airway exchange catheter with rapifit adapter 14 french was used to exchange a tracheostomy and the ifu state the device is intended to exchange an endotracheal tube. A large amount of hemoptysis was noted post trach change. The hemoptysis lasted less than 4-hrs. On (b)(6) 2018 additional information was received that the sputum culture was done due to signs of infection. It was reported that prior to the trach change the sputum appeared pink and frothy and that there was not any frank blood in it. The customer stated that it was difficult to estimate the patient's blood loss. The customer stated they would classify it as moderate. After the trach change, frank hemoptysis was noted. It was not believed that this was due to suction. It was felt the trach being loose in the airway caused irritation but that what was seen could have been pulmonary edema also. The customer reported that the changing of the trach definitely caused the patient to bleed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03410 |
| MDR Report Key | 8112943 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2018-11-28 |
| Date of Report | 2019-02-07 |
| Date of Event | 2018-10-01 |
| Date Mfgr Received | 2019-01-10 |
| Date Added to Maude | 2018-11-28 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8123392235 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNKNOWN |
| Generic Name | LRC CHANGER, TUBE, ENDOTRACHEAL |
| Product Code | LRC |
| Date Received | 2018-11-28 |
| Catalog Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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. Other | 2018-11-28 |