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 2018-12-20 for manufactured by Unomedical S.r.o..
[131135768]
Brand name: connecting tube; noninvasive tubing. Common device name: vacuum-powered body fluid suction apparatus. (b)(6). Although requested the product lot number could not be provided. Based on the available information, this event is deemed to be a serious injury. No lot number is available. A detailed investigation or batch review cannot be conducted. Therefore, this evaluation will be closed. This issue will be monitored through the post market product monitoring review process. 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
[131135769]
It was reported a? Patient with serious copd (chronic obstructive pulmonary disease) and treated with oxygen in the home was admitted to (b)(6) hospital on (b)(6) 2017.? On the evening of (b)(6) 2017 at approximately 22:00pm, it was noted the patient experienced abdominal pain. The nurse reported that when she left the room to get painkillers, she returned to find that the patient was unconscious and heavily swollen throughout the body. They reported that the patient had bleeding from the right ear and had general subcutaneous emphysema. The patient was declared dead. ? When the body is put in order it is discovered that the oxygen line had been connected to the urinary tract catheter?. The reported official cause of death was due to air embolism. Additional information received from the hospital and physician, confirmed the patient was in a single room, and the oxygen source was placed at the right side behind the bed at the wall approximately 120 meters from the floor. The catheter was confirmed to be located at the bottom of the bed. It was stated that? They don? T know if the patient or the staff connected the oxygen tube with the catheter.? The reporter noted that the product was handled the wrong way and was used for the wrong purpose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005778470-2018-00033 |
| MDR Report Key | 8186679 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,O |
| Date Received | 2018-12-20 |
| Date of Event | 2017-05-18 |
| Date Mfgr Received | 2018-11-29 |
| Date Added to Maude | 2018-12-20 |
| 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 G1 | UNOMEDICAL S.R.O. |
| Manufacturer Street | PRIEMYSELNY PARK 3, |
| Manufacturer City | MICHALOVCE 07101 |
| Manufacturer Country | LO |
| Manufacturer Postal Code | 07101 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Product Code | GAZ |
| Date Received | 2018-12-20 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL S.R.O. |
| Manufacturer Address | PRIEMYSELNY PARK 3, MICHALOVCE 07101 LO 07101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-20 |