MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2011-11-28 for NON-STERILE VENTRICULAR CATHETER STYLET NL7801301 manufactured by Integra Neurosciences Pr.
[2318652]
On (b)(6) 2011, the customer contacted an integra sales representative stating that the product was used "last night believing it was sterile in a patient. " the customer stated "it is non-sterile. Why is it packaged sterile, and they placed this non sterile product in a patient last night. " integra contacted the customer on (b)(4) 2011 and it was reported by the customer that the product was used on the patient during a shunt revision on(b)(6) 2011. Multiple attempts to obtain additional clinical information was made to the customer. However, no response from the customer was received. (b)(4): "stylet used for ventricular catheter. Outside package opened onto sterile field. Inside package says "non sterile for single use only. " the inside pamphlet says "sterile/eo. " the insert also says "all of the products are supplied individually in a sterile, pyroge -free double wrap packaging system. " staff did not realize that item was not sterile and it was inserted into brain. " the patient is a (b)(6) male patient. The date of the event was on (b)(6) 2011. The original intended procedure was reported as a ventricular catheter placement. The patient has lymphoma with central nervous system (cns) involvement. The patient was given prophylactic antibiotics. No other therapies were in use on the patient. Other devices in use on patient were reported as none. The device is available to be returned for evaluation. On (b)(4) 2011, the (b)(6) was contacted by integra and it was clarified that the onset date of the event was (b)(4) 2011 and not what was reported to the fda of (b)(6) 2011. The product has been discarded and not available to be returned for evaluation. On (b)(4) 2011, additional clinical information was requested by integra and on (b)(6) 2011, the (b)(6) provided the following information: the "surgery (incident) was done late in the evening of (b)(6) 2011. " the stylet that was involved in this incident was discarded and not available for evaluation. The patient was given prophylactic antibiotics. "on (b)(6), he was discharged to home. He returned late the same night as discharged. He was febrile and lethargic. " patient outcome was reported as "died on (b)(6) 2011. " on (b)(6) 2011, additional information was received from the (b)(6) that the cause of death was unknown at this time. The customer was awaiting for the death summary and any autopsy results if one was done. Note: the (b)(4) is labeled as "non-sterile. " the product ordering code in non-sterile. Included with the non-sterile stylet is the package insert for the pudenz ventricular catheter set. There is a pudenz ventricular catheter set available that contains a stylet and package insert which is labeled sterile. Cross referenced to (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9495445]
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 | 2023988-2011-00047 |
| MDR Report Key | 2357656 |
| Report Source | 05,06,07 |
| Date Received | 2011-11-28 |
| Date of Report | 2011-11-28 |
| Date of Event | 2011-11-02 |
| Date Mfgr Received | 2011-11-02 |
| Date Added to Maude | 2011-12-06 |
| 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 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 | 1. Death | 2011-11-28 |