MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-09 for UCH CUSTOM BLOCK TRAY 2581 manufactured by Busse Hosp Disposables.
[3449330]
(b)(6) health custom block tray, cat #: busse 2582, lot #: 1330075. Complaint number filed with (b)(4). Tray was opened to use in pt procedure and noted to have small black "things" in the barrel of the syringe. The "things" when looked at under a magnifying glass looked to be fleas. This product never reached the pt, and all product with this lot number were pulled. This product is being returned to (b)(4) hosp disposables for eval and report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5030153 |
| MDR Report Key | 3114072 |
| Date Received | 2013-05-09 |
| Date of Report | 2013-05-09 |
| Date of Event | 2013-05-03 |
| Date Added to Maude | 2013-05-16 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UCH CUSTOM BLOCK TRAY |
| Generic Name | BLOCK TRAY |
| Product Code | FCH |
| Date Received | 2013-05-09 |
| Model Number | 2581 |
| Lot Number | 1330075 |
| Device Expiration Date | 2014-10-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BUSSE HOSP DISPOSABLES |
| Manufacturer Address | 75 ARKAY DR HAUPPAUGE NY 11788 US 11788 |
| Brand Name | UCH CUSTOM BLOCK TRAY |
| Generic Name | BLOCK TRAY |
| Product Code | FCH |
| Date Received | 2013-05-09 |
| Model Number | 2582 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BUSSE HOSP DISPOSABLES |
| Manufacturer Address | 75 ARKAY DR HAUPPAUGE NY 11788 US 11788 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-09 |