MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2009-11-17 for STIMUPLEX INSULATED NEEDLE 333690 manufactured by B. Braun Medical Inc..
[19052418]
As reported by the user facility. Reports doing interscalene block, needle functioned normally through procedure. Anesthesiologist attempted to remove needle and hub separated from needle. Necessitating an incision be made to retrieve needle under fluoroscopy. All of needle removed. Patient has been in for follow-up with physician and no problems from needle removal reported.
Patient Sequence No: 1, Text Type: D, B5
[19121128]
The actual device in the reported incident was returned to the manufacturer to be evaluated. The needle was bent at a 90 degree angle approximately 1 1/2" from the tip of the cannula. The hub end of the needle had a jagged appearance, indicating the needle broke off at the hub and did not detach from the hub. The hub of the needle and the extension set were not returned for evaluation. Incidents of this nature are generally due to the cannula encountering some type of trauma which stressed the part beyond its intended design capabilities. This may be the case in this incident especially since it appears that the returned portion of the needle was bent on a 90 degree angle and broken off at the hub. The sample and all available information has been forwarded to the actual manufacturer for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523676-2009-00108 |
| MDR Report Key | 1564999 |
| Report Source | 06 |
| Date Received | 2009-11-17 |
| Date of Report | 2009-12-16 |
| Date of Event | 2009-10-21 |
| Date Mfgr Received | 2009-12-04 |
| Device Manufacturer Date | 2009-09-01 |
| Date Added to Maude | 2011-02-11 |
| 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 | KIMBERLY PARIS |
| Manufacturer Street | 901 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 6102660500 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STIMUPLEX INSULATED NEEDLE |
| Generic Name | STIMUPLEX NEEDLE |
| Product Code | BXN |
| Date Received | 2009-11-17 |
| Returned To Mfg | 2009-12-16 |
| Model Number | NA |
| Catalog Number | 333690 |
| Lot Number | 61071869 |
| ID Number | NA |
| Device Expiration Date | 2013-12-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Manufacturer Address | ALLENTOWN PA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2009-11-17 |