MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-10-31 for PENCAN SPINAL NEEDLE TRAY P25PTK 333854 manufactured by B. Braun Medical Inc..
[16719393]
As reported by the sales rep per the user facility: pencan spinal needle broke at hub while in the patients back. Needle was able to be retrieved without additional surgery. Additional information provided by the facility indicated the needle fragment was retrieved without incident and the patient suffered no adverse sequela associated with this incident. The sample was discarded and is not available for evaluation.
Patient Sequence No: 1, Text Type: D, B5
[16907433]
The actual device in the incident was not made available for the manufacturer to evaluate. Without the actual sample, a thorough evaluation could not be performed. Incidents of this nature are generally due to the cannula encountering some type of trauma (bone contact), which stressed the part beyond its intended design capabilities. However, no specific conclusions can be drawn.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523676-2006-00092 |
| MDR Report Key | 777964 |
| Report Source | 06 |
| Date Received | 2006-10-31 |
| Date of Report | 2006-10-24 |
| Date of Event | 2006-10-02 |
| Date Mfgr Received | 2006-10-03 |
| Device Manufacturer Date | 2006-06-01 |
| Date Added to Maude | 2006-11-08 |
| 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 | 3 |
| Event Location | 0 |
| Manufacturer Contact | KIKOO TEJWANI |
| Manufacturer Street | 901 MARCON BLVD. |
| Manufacturer City | ALLENTOWN PA 18109 |
| Manufacturer Country | US |
| Manufacturer Postal | 18109 |
| Manufacturer Phone | 6102660500 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PENCAN SPINAL NEEDLE TRAY |
| Generic Name | PENCAN SPINAL TRAY |
| Product Code | HAS |
| Date Received | 2006-10-31 |
| Model Number | P25PTK |
| Catalog Number | 333854 |
| Lot Number | 60862305 |
| ID Number | NA |
| Device Expiration Date | 2007-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 765742 |
| Manufacturer | B. BRAUN MEDICAL INC. |
| Manufacturer Address | * ALLENTOWN PA 18109 US |
| Baseline Brand Name | PENCAN |
| Baseline Generic Name | SPINAL TRAY |
| Baseline Model No | P25PTK |
| Baseline Catalog No | 333854 |
| Baseline ID | NA |
| Baseline Device Family | SPINAL TRAY |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 60 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K932569 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-10-31 |