MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-11 for 59043C manufactured by Medical Action Industries, Inc.
[25507921]
Patient Sequence No: 1, Text Type: N, H10
[25507922]
This facility experienced a similar event approximately one year ago when several like kits were identified with same issue of the needle bending when attempts were made to access a patient's portacath. This is a different lot number but appears to be a similar issue. As the nurse was attempting to access the portacath, the micro gripper needle bent (smiths medical gripper micro:re-order # (b)(4), lot # 34x861). A new gripper needle was used without difficulty. There was no known patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5069846 |
| MDR Report Key | 5069846 |
| Date Received | 2015-09-11 |
| Date of Report | 2015-08-07 |
| Date of Event | 2015-02-03 |
| Report Date | 2015-03-31 |
| Date Reported to FDA | 2015-03-31 |
| Date Reported to Mfgr | 2015-03-31 |
| Date Added to Maude | 2015-09-11 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | PORT ACCESS, KIT |
| Product Code | LRS |
| Date Received | 2015-09-11 |
| Catalog Number | 59043C |
| Device Expiration Date | 2016-05-01 |
| Operator | NURSE |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES, INC |
| Manufacturer Address | 25 HEYWOOD RD. ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-11 |