MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2011-11-28 for NON-STERILE VENTRICULAR CATHETER STYLET NL7801301 manufactured by Integra Neurosciences Pr.
[2313920]
On (b)(6) 2011, it was reported by the injury prevention coordinator from the user facility's risk management department that a non-sterile stylet ((b)(4): non-sterile ventricular catheter stylet) was used on a (b)(6) female pt for a t3-l3 fusion with instrumentation on (b)(6) 2011 at 17:00. The non-sterile stylet was discovered intraoperatively. It was reported that the pt had already been given prophylactic antibiotics and antibiotics were mixed with the bone cement. The surgery was stopped. The pt was re-prepped and given extra antibiotics. Surgery continued. No wound infection was noted. It was reported that the pt had developed a urinary tract infection (uti) after the surgery on (b)(6) 2011. Antibiotics were given. The pt was discharged on (b)(6) 2011. On (b)(6) 2011, additional information was requested form the injury prevention coordinator and it was reported that form the surgical report that the stylet was "used to reclean suction". No other information was available. No cultures were done at the site whether the product was used. Note: the product has a label that states "non-sterile". The product ordering code indicates that this product is non-sterile.
Patient Sequence No: 1, Text Type: D, B5
[9493186]
The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2648988-2011-00051 |
| MDR Report Key | 2358229 |
| Report Source | 05,06 |
| Date Received | 2011-11-28 |
| Date of Report | 2011-11-28 |
| Date of Event | 2011-11-01 |
| Date Mfgr Received | 2011-11-22 |
| Date Added to Maude | 2011-12-07 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | ROWENA SALVADOR |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099365581 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NON-STERILE VENTRICULAR CATHETER STYLET |
| Generic Name | NA |
| Product Code | HCA |
| Date Received | 2011-11-28 |
| Catalog Number | NL7801301 |
| Lot Number | 1082137 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA NEUROSCIENCES PR |
| Manufacturer Address | ANASCO PR 00610 US 00610 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-11-28 |