MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-05-03 for MEDICAL ACTION INDUSTRIES 267004 manufactured by Medical Action Industries.
[45102097]
Upon receipt of the report, mai initiated an internal product complaint, (b)(4). We have reviewed our complaint database, and at this time we do not have any notable trends for this issue related to the component as pertains to any convenience kits which contains this style item. Mai initiated a vendor scar (supplier corrective action request) and supplied a copy of the received medwatch to the supplier carefusion on 04/13/2016. Carefusion was provided customer contact information for sample retrieval and evaluation. At this time, their investigation has not concluded.
Patient Sequence No: 1, Text Type: N, H10
[45102098]
On 04/05/2016, medical action industries (mai), an owens & minor company, received medwatch (b)(4) stating that a nurse was cut by a shard protruding from chloraprep sepp applicator, ref: 260449, when she went to activate the applicator for an iv start skin prep procedure. This component was one of several components which are packaged by mai medical action industries iv start convenience kit, 267004. The end-user did not indicate a kit or component lot number associated with the product. Mai has confirmed with the hospital that the employee involved had their wound appropriately dressed and cleaned. The hospital reported this issue as a product problem. The chloraprep sepp applicator involved in this incident is manufactured by carefusion. This component in its original component packaging is packaged by mai with other medical components to produce mai iv start convenience kit, 267004.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1030451-2016-00008 |
| MDR Report Key | 5625294 |
| Date Received | 2016-05-03 |
| Date of Report | 2016-04-29 |
| Date of Event | 2015-12-07 |
| Date Mfgr Received | 2016-04-05 |
| Date Added to Maude | 2016-05-03 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | NICHOLE EARLY |
| Manufacturer Street | 25 HEYWOOD ROAD |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal | 28704 |
| Manufacturer Phone | 8283387568 |
| Manufacturer G1 | MEDICAL ACTION INDUSTRIES |
| Manufacturer Street | 25 HEYWOOD ROAD |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 28704 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDICAL ACTION INDUSTRIES |
| Generic Name | KIT: IV 100/CS |
| Product Code | LRS |
| Date Received | 2016-05-03 |
| Model Number | 267004 |
| Catalog Number | 267004 |
| Lot Number | UNKNOWN |
| Operator | NURSE |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL ACTION INDUSTRIES |
| Manufacturer Address | 25 HEYWOOD ROAD ARDEN NC 28704 US 28704 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-05-03 |