MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-07-03 for * 59043C manufactured by Medical Action Industries, Inc.
[19925779]
There have been four known instances when the needle bent as the nurse was attempting to access the portacath. The needle is currently distributed by smith's medical, but was formerly deltec. The nurses described the needle as "giving way" upon entry into the port. The nurses have experience with using the needle. There was no patient harm in any of the four events. Manufacturer response for blunt cannula non coring safety needle, gripper micro (per site reporter). ======================the smiths medical rep came immediately to the facility to meet with team, and assisted staff with replacement of this needle lot 34x136. This was difficult as this needle is part of a port access kit which is assembled by medical action industries, inc. These kits also had to be identified.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3965952 |
| MDR Report Key | 3965952 |
| Date Received | 2014-07-03 |
| Date of Report | 2014-07-03 |
| Date of Event | 2014-06-23 |
| Report Date | 2014-07-03 |
| Date Reported to FDA | 2014-07-03 |
| Date Reported to Mfgr | 2014-07-30 |
| Date Added to Maude | 2014-07-30 |
| 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 | * |
| Generic Name | PORT ACCESS, KIT |
| Product Code | LRS |
| Date Received | 2014-07-03 |
| Returned To Mfg | 2014-07-02 |
| Model Number | * |
| Catalog Number | 59043C |
| Lot Number | 187966 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES, INC |
| Manufacturer Address | 500 EXPRESSWAY DRIVE SOUTH BRENTWOOD NY 11717 US 11717 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-07-03 |