MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2015-06-25 for STERILE TIP CLEANER TC-100B manufactured by Aspen Surgical Products, Inc..
[6072681]
Customer rejected 1 piece due to packing failure. Sterile barrier breach.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1836161-2015-00047 |
| MDR Report Key | 4892584 |
| Report Source | 08 |
| Date Received | 2015-06-25 |
| Date of Report | 2015-06-25 |
| Date of Event | 2015-05-25 |
| Date Mfgr Received | 2015-06-04 |
| Date Added to Maude | 2015-07-21 |
| 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 | BRADLEY LISKE |
| Manufacturer Street | 6945 SOUTHBELT DR. S.E. |
| Manufacturer City | CALEDONIA MI 49316 |
| Manufacturer Country | US |
| Manufacturer Postal | 49316 |
| Manufacturer Phone | 6166987100 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERILE TIP CLEANER |
| Generic Name | STERILE TIP CLEANER |
| Product Code | KXG |
| Date Received | 2015-06-25 |
| Model Number | TC-100B |
| Lot Number | 69117 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ASPEN SURGICAL PRODUCTS, INC. |
| Manufacturer Address | CALEDONIA MI US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-25 |