MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,o report with the FDA on 2020-03-26 for FINGERTIP 36011181 manufactured by Unomedical Zavodskaya Street 50.
[186321881]
Mdr 3007966929-2020-00010 / device 1 of 2. (b)(6). Based on the available information, this event is deemed to be a serious injury. To date no additional information has been received. Should additional information become available, a follow-up report will be submitted. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[186321882]
It was reported the "suction catheter pouch fill up with air even though block controller is off to the patient/intubation tube". End user reports "they can't input the catheter to the intubation tube if the pouch is fill up with air". The patient was on respirator in the intensive care unit at the user facility with closed suction system connected to intubation tube, there was air in the suction bag and suction could not be done. The patient needed airway aspiration quickly and treatment was delayed due to incorrect suction. " no photographs were received depicting the reported complaint issue. There was no initial report of harm to the patient when report was first made.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007966929-2020-00010 |
| MDR Report Key | 9884716 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2020-03-26 |
| Date of Event | 2019-10-18 |
| Date Mfgr Received | 2020-03-04 |
| Date Added to Maude | 2020-03-26 |
| 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 | MS. JEANETTE JOHNSON |
| Manufacturer Street | 7900 TRIAD CENTER DRIVE SUITE 400 |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 3365424681 |
| Manufacturer G1 | UNOMEDICAL ZAVODSKAYA STREET 50 |
| Manufacturer Street | FE UNOMEDICAL LTD MINSK REGION |
| Manufacturer City | MINSKAYA VOBLASTS |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FINGERTIP |
| Generic Name | CATHETER AND TIP, SUCTION |
| Product Code | JOL |
| Date Received | 2020-03-26 |
| Model Number | 36011181 |
| Lot Number | 322223 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL ZAVODSKAYA STREET 50 |
| Manufacturer Address | FE UNOMEDICAL LTD MINSK REGION MINSKAYA VOBLASTS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-26 |