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 2019-03-19 for GLIDERITE? SINGLE-USE STYLET 0270-0916 0803-0118 manufactured by Verathon Medical Ulc.
[139306400]
Verathon continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803. 56 when additional information becomes available.
Patient Sequence No: 1, Text Type: N, H10
[139306401]
Verathon received a user facility report stating that during a patient procedure, using a gliderite single use stylet, the stylet broke inside the endotracheal (et) tube. During a follow up call the customer stated that the respiratory therapist (rt) was using the stylet to intubate a twelve day old infant. The initial attempt to intubate the patient with a single lumen et tube was unsuccessful. The et tube , with the stylet still inserted, was removed from the patient's mouth. The rt used the same single use stylet and with a dual lumen et tube to successfully intubate the patient. Reportedly the patient arrived at the hospital with the et tube and stylet still in place. The patient was ventilating and was well oxygenated upon arrival at the hospital, however the patient passed away due to unrelated complications. When the et tube was removed it was noted that stylet, which had remained in the et tube, had broken but remained inside the et tube. The customer indicated that the patient outcome was not a result of the broken stylet.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9615393-2019-00056 |
| MDR Report Key | 8434867 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-03-19 |
| Date of Report | 2019-02-18 |
| Date of Event | 2019-02-01 |
| Date Mfgr Received | 2019-02-18 |
| Date Added to Maude | 2019-03-19 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. COREY KASBOHM |
| Manufacturer Street | 20001 N CREEK PKWY |
| Manufacturer City | BOTHELL WA 980118218 |
| Manufacturer Country | US |
| Manufacturer Postal | 980118218 |
| Manufacturer Phone | 4256295760 |
| Manufacturer G1 | VERATHON MEDICAL ULC |
| Manufacturer Street | 2227 DOUGLAS ROAD |
| Manufacturer City | BURNABY, BRITISH COLUMBIA V5C 5A9 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | V5C 5A9 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GLIDERITE? SINGLE-USE STYLET |
| Generic Name | STYLET, TRACHEAL TUBE |
| Product Code | BSR |
| Date Received | 2019-03-19 |
| Model Number | 0270-0916 |
| Catalog Number | 0803-0118 |
| Lot Number | GS43228 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VERATHON MEDICAL ULC |
| Manufacturer Address | 2227 DOUGLAS ROAD BURNABY, BRITISH COLUMBIA V5C 5A9 CA V5C 5A9 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-03-19 |