MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-27 for MEDICAL ACTION INDUSTRIES 267014 manufactured by Medical Action Industries Inc..
[92924723]
Patient Sequence No: 1, Text Type: N, H10
[92924724]
Ed staff stocking iv trays with medical action iv start kits ref (b)(4) lot 237861 and at least (7) sealed packages present in case container without any contents present(tourniquet, tape, chloraprep frepp, gauze, tegaderm, or iv change label).
Patient Sequence No: 1, Text Type: D, B5
[106339192]
Patient Sequence No: 1, Text Type: N, H10
[106339193]
Ed staff stocking iv trays with medical action iv start kits ref 267014 lot 237861 and at least (7) sealed packages present in case container without any contents present(tourniquet, tape, chloraprep frepp, gauze, tegaderm, or iv change label).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7058618 |
| MDR Report Key | 7058618 |
| Date Received | 2017-11-27 |
| Date of Report | 2017-11-16 |
| Date of Event | 2017-10-30 |
| Report Date | 2017-10-31 |
| Date Reported to FDA | 2017-10-31 |
| Date Reported to Mfgr | 2017-10-31 |
| Date Added to Maude | 2017-11-27 |
| 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDICAL ACTION INDUSTRIES |
| Generic Name | I.V. START KIT |
| Product Code | LRS |
| Date Received | 2017-11-27 |
| Model Number | 267014 |
| Lot Number | 237861 |
| Device Availability | Y |
| Device Age | DA |
| 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 | 2017-11-27 |