MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-21 for TUBING ANCHOR SECUREMENT DEVICE ANC32XT manufactured by Centurion Medical Products Corp..
[176078369]
When using "tubing anchor securement device," securing band snapped and broke. Unable to use the device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092378 |
| MDR Report Key | 9616179 |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-06 |
| Date of Event | 2019-12-30 |
| Date Added to Maude | 2020-01-22 |
| 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 | RISK MANAGER |
| 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 | TUBING ANCHOR SECUREMENT DEVICE |
| Generic Name | DEVICE, INTRAVASCULAR CATHETER, SECUREMENT |
| Product Code | KMK |
| Date Received | 2020-01-21 |
| Catalog Number | ANC32XT |
| Lot Number | 2019041290 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CENTURION MEDICAL PRODUCTS CORP. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-21 |