MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-07 for TRAY, PORT-A-CATH ACCESS DYNDC1800 manufactured by Medline.
[107770058]
Opened a "sterile" port a cath access tray and placed items on a sterile field using sterile technique. Upon inspection, package was noted to have a hole in the middle of the sterile field next to the tray. Replaced the tray and entire contents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077069 |
| MDR Report Key | 7494303 |
| Date Received | 2018-05-07 |
| Date of Report | 2018-05-04 |
| Date of Event | 2018-03-29 |
| Date Added to Maude | 2018-05-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TRAY, PORT-A-CATH ACCESS |
| Generic Name | TRAY, PORT-A-CATH ACCESS |
| Product Code | OKE |
| Date Received | 2018-05-07 |
| Catalog Number | DYNDC1800 |
| Lot Number | 17LB9811 |
| Device Expiration Date | 2019-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-07 |