MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-22 for INTERLINK DG536001 3004139 manufactured by Becton, Dickinson & Co..
[20711054]
Neupogen was used and put back in the refrigerator on pcu (patient care unit). A needleless blunt was used to draw it up and the stopper went inside the vial. No harm to staff or the patient. The bd rep came to materials management - gave him the blunt (in package). The cancer center sent over with their product failure reports. Also showed him the neupogen vial that was sent to materials management. He mainly took down information, and is looking for more defective samples and lot information as we have it. The rep said that he has not heard of any issues like this going on anywhere else, and mentioned the rubber stoppers at times can have issues, but he certainly took our complaint seriously and is going to do everything he can to research it. Materials management will continue to monitor and accept any other product failures, hopefully with samples and packing of the defective blunts. What was the original intended procedure? Drawing up medicine for patient. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3151349 |
| MDR Report Key | 3151349 |
| Date Received | 2013-05-22 |
| Date of Report | 2013-05-22 |
| Date of Event | 2013-03-11 |
| Report Date | 2013-05-22 |
| Date Reported to FDA | 2013-05-22 |
| Date Reported to Mfgr | 2013-06-07 |
| Date Added to Maude | 2013-06-07 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | INTERLINK |
| Generic Name | CANNULA, INJECTION |
| Product Code | FGY |
| Date Received | 2013-05-22 |
| Model Number | DG536001 |
| Catalog Number | 3004139 |
| Lot Number | (01) 00382903034031 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BECTON, DICKINSON & CO. |
| Manufacturer Address | ONE BECTON DRIVE FRANKLIN LAKES NJ 07417188 US 07417 1884 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-22 |