MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-03 for MUCUS SPECIMEN TRAP 40 CC C30200A manufactured by Medline Industries, Inc..
[39597760]
Patient Sequence No: 1, Text Type: N, H10
[39597761]
The respiratory staff found an insect inside the unopened sterile package. I have pictures if you wish.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5477338 |
| MDR Report Key | 5477338 |
| Date Received | 2016-03-03 |
| Date of Report | 2016-01-20 |
| Date of Event | 2016-01-20 |
| Report Date | 2016-01-20 |
| Date Reported to FDA | 2016-01-20 |
| Date Reported to Mfgr | 2016-01-20 |
| Date Added to Maude | 2016-03-03 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| 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 | 3 |
| Brand Name | MUCUS SPECIMEN TRAP 40 CC |
| Generic Name | TRAP, STERILE SPECIMEN |
| Product Code | BYZ |
| Date Received | 2016-03-03 |
| Catalog Number | C30200A |
| Lot Number | 20150702_SH |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES, INC. |
| Manufacturer Address | ONE MEDLINE PLACE MUNDELEIN IL 60060 US 60060 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-03 |