MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2016-09-07 for 22G X 14.9CM (5.875 INCH) CHIBA NEEDLE 0921225000 manufactured by Stryker Instruments-kalamazoo.
[54144058]
It was reported the tip fractured off the device during a procedure at the healthcare facility. The tip was removed and the procedure was completed successfully. It was also reported there was no impact on the patient and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
[93609077]
Corrected information: device not available for return.
Patient Sequence No: 1, Text Type: N, H10
[93609078]
It was reported the tip fractured off the device during a procedure at the healthcare facility. The tip was removed and the procedure was completed successfully. It was also reported there was no impact on the patient and no adverse consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 0001811755-2016-02136 |
| MDR Report Key | 5934565 |
| Report Source | USER FACILITY |
| Date Received | 2016-09-07 |
| Date of Report | 2017-09-18 |
| Date of Event | 2016-07-01 |
| Date Mfgr Received | 2016-08-08 |
| Date Added to Maude | 2016-09-07 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. CASEY METZGER |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal | 49001 |
| Manufacturer Phone | 2693237700 |
| Manufacturer G1 | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Street | 4100 EAST MILHAM AVENUE |
| Manufacturer City | KALAMAZOO MI 49001 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 49001 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 22G X 14.9CM (5.875 INCH) CHIBA NEEDLE |
| Generic Name | DEVICE, PERCUTANEOUS, BIOPSY |
| Product Code | MJG |
| Date Received | 2016-09-07 |
| Catalog Number | 0921225000 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER INSTRUMENTS-KALAMAZOO |
| Manufacturer Address | 4100 EAST MILHAM AVENUE KALAMAZOO MI 49001 US 49001 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-09-07 |