MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other,user facility report with the FDA on 2020-02-25 for BD NEEDLE SP S/SU 25GA TW 3-1/2IN WHITACRE 405138 manufactured by Bd Caribe Ltd..
[182211443]
Date of event: unknown. The date received by manufacturer has been used for this field. Initial reporter phone #: unknown; additional contact phone # was provided: (b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[182211444]
It was reported that the needle pulled out during use and remained in injection site resulting in surgery to remove with a bd needle sp s/su 25ga tw 3-1/2in whitacre. The following information was provided by the initial reporter: it was reported the needle sheared off in a patient's back resulting in the patient having surgery to get it removed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2618282-2020-00010 |
| MDR Report Key | 9751329 |
| Report Source | OTHER,USER FACILITY |
| Date Received | 2020-02-25 |
| Date of Report | 2020-02-05 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2018-04-10 |
| Date Added to Maude | 2020-02-25 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX BRETT WILKO |
| Manufacturer Street | 9450 SOUTH STATE STREET |
| Manufacturer City | SANDY UT 84070 |
| Manufacturer Country | US |
| Manufacturer Postal | 84070 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | BD CARIBE LTD. |
| Manufacturer Street | ROAD 31 K.M. 24.3 |
| Manufacturer City | JUNCOS |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BD NEEDLE SP S/SU 25GA TW 3-1/2IN WHITACRE |
| Generic Name | ANESTHESIA CONDUCTION NEEDLE |
| Product Code | BSP |
| Date Received | 2020-02-25 |
| Model Number | 405138 |
| Catalog Number | 405138 |
| Lot Number | 8058777 |
| Device Availability | * |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BD CARIBE LTD. |
| Manufacturer Address | ROAD 31 K.M. 24.3 JUNCOS US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-25 |