MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-05-04 for V. MUELLER BE8230 manufactured by Bd (carefusion 2200, Inc).
[74438128]
Patient Sequence No: 1, Text Type: N, H10
[74438129]
Patient experienced retention of a 6 cm needle sheath of a 22ga mediastinoscopy aspirating needle. The 6 cm sheath is a sliding piece over the needle. When the needle was inserted during a surgical case performed approximately 7 months ago, the sliding piece was retained. Needle was used to inject local anesthetics. The patient was discharged to home, but later reported discomfort. X-rays confirmed metallic object. Patient returned to have the object removed approximately one month ago.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6544420 |
| MDR Report Key | 6544420 |
| Date Received | 2017-05-04 |
| Date of Report | 2017-04-26 |
| Date of Event | 2016-09-13 |
| Report Date | 2017-04-26 |
| Date Reported to FDA | 2017-04-26 |
| Date Reported to Mfgr | 2017-04-26 |
| Date Added to Maude | 2017-05-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| 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 | V. MUELLER |
| Generic Name | NEEDLE, HYPODERMIC, SINGLE LUMEN |
| Product Code | DWO |
| Date Received | 2017-05-04 |
| Model Number | BE8230 |
| Catalog Number | BE8230 |
| ID Number | 22GA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | BD (CAREFUSION 2200, INC) |
| Manufacturer Address | 5859 FARINON DR. STE. 200 SAN ANTONIO TX 78249 US 78249 |
| Brand Name | V. MUELLER |
| Generic Name | NEEDLE, HYPODERMIC, SINGLE LUMEN |
| Product Code | FMI |
| Date Received | 2017-05-04 |
| Model Number | BE8230 |
| Catalog Number | BE8230 |
| ID Number | 22GA |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD (CAREFUSION 2200, INC) |
| Manufacturer Address | 5859 FARINON DR. STE. 200 SAN ANTONIO TX 78249 US 78249 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-04 |