MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,08 report with the FDA on 2014-05-30 for CATHY-CLOSED S.CH12 45CM/78 36011182 manufactured by Unomedical Ltd..
[4583681]
It was reported "inflation of catheter sleeve (making it difficult to manipulate the catheter due to the air pressure); moisture build-up inside the sleeve. " note: this reported issue occurred on five separate cases.
Patient Sequence No: 1, Text Type: D, B5
[12033432]
Based on the available information, this event is deemed a reportable malfunction. It was further reported the "hospital is concerned with infection. " additional event information was provided via email on (b)(4) 2014 informing that they replaced the device due to the continued issues with sleeve inflation and moisture build-up. No information was provided or reported that any infections had occurred to patient(s); they further informed that they cannot determine exact number of patient(s) involved and the product was used in the surgical intensive care unit. They went on to inform that it is unknown how long the product was in use prior to the event occurring. Issues occurred on five (5) separate cases. A separate 3500a form has been completed for the other (4) cases under patient identifier(s) (b)(4). Mfr reports #: 3007966929-2014-00017, 00019, 00021 and 00023 respectively. (report 5 of 5) no additional patient/event details have been provided to date. Should additional information become available a follow-up report will be submitted. Note: the actual date of event is unknown, so the date used was the date convatec became aware.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007966929-2014-00025 |
| MDR Report Key | 3908201 |
| Report Source | 01,05,06,07,08 |
| Date Received | 2014-05-30 |
| Date of Report | 2014-04-30 |
| Date of Event | 2014-04-30 |
| Date Mfgr Received | 2014-04-30 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2014-07-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATTHEW WALENCIAK, INT. ASS. DIR |
| Manufacturer Street | 211 AMERICAN AVE. |
| Manufacturer City | GREENSBORO NC 27409 |
| Manufacturer Country | US |
| Manufacturer Postal | 27409 |
| Manufacturer Phone | 9083779293 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CATHY-CLOSED S.CH12 45CM/78 |
| Generic Name | CATHETER, NASAL, OXYGEN |
| Product Code | BZB |
| Date Received | 2014-05-30 |
| Model Number | 36011182 |
| Catalog Number | 36011182 |
| Lot Number | 635427 |
| Device Expiration Date | 2013-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | UNOMEDICAL LTD. |
| Manufacturer Address | ZAVODSKAYA STREET 50 FANIPOL DZERZHINSK DISTRICT, MINSK REGION MINSKAYA VOBLASTS 222750 BO 222750 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-05-30 |