MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,08 report with the FDA on 2013-10-25 for ICU/O2 & AEROSOL/CATHETER 19057339 manufactured by Convatec Inc.
[4149876]
It is reported that the foam pad is loose and that the foam remains in the packaging container upon removal. It is reported that the foam stays in the nose of the pt. Sixteen samples were taken to a visual examination in accordance to the drawing (demanded: foam should be glued at the catheter; actual: the foam is loose at three samples).
Patient Sequence No: 1, Text Type: D, B5
[11255215]
Based on the available info, this event is deemed a reportable malfunction. No reports of a pt being harmed as a result of this malfunction. Add'l info received indicates that sixteen samples without peel pack were received and tested. Results show that twelve samples did not meet test requirements and that the foam did come loose at catheters. For samples that were strength tested, results show that all met specs. History records were reviewed and no nonconformity of this nature was registered during mfg process. All relevant tests required during mfg process and final product releases were performed and met requirements. No earlier complaint has been received on the batch. Note: the actual date of event is unk, so the date used to the date convatec became aware.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005778470-2013-00041 |
| MDR Report Key | 3492123 |
| Report Source | 07,08 |
| Date Received | 2013-10-25 |
| Date of Report | 2013-09-27 |
| Date of Event | 2013-09-27 |
| Date Mfgr Received | 2013-09-27 |
| Device Manufacturer Date | 2012-08-01 |
| Date Added to Maude | 2014-01-27 |
| 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 | MARY SZARO, ASSOC DIR |
| Manufacturer Street | 200 HEADQUARTERS PK DR |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9083042450 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ICU/O2 & AEROSOL/CATHETER |
| Generic Name | CATHETER, NASAL, OXYGEN |
| Product Code | BZB |
| Date Received | 2013-10-25 |
| Model Number | 19057339 |
| Catalog Number | 19057339 |
| Lot Number | 453346 |
| Device Expiration Date | 2017-07-01 |
| Operator | OTHER |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC INC |
| Manufacturer Address | PRIEMYSELNY PARK 3 MICHALOVCE 07101 LO 07101 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-10-25 |