MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05 report with the FDA on 2013-11-20 for NONE manufactured by Medical Action Industries, Inc..
[4120307]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11468561]
The customer, (b)(6), complained that a chlorhexidine ampule (chloraprep sepp) in the i. V. Start kit had splintered when breaking open. The incident occurred on (b)(6) 2013 but the customer report to fda was dated on (b)(4) 2013. (b)(4). Medical action industries inc. ("mai") manufactures the i. V. Start kit that contained the ampule, but the ampule is made by carefusion. The medwatch did not indicate if there was an injury related to this report and had only minimal info on the description of the event or problem. We immediately contacted carefusion, the chloraprep sepp manufacturer to obtain additional info and to inform them of the medwatch. The customer's medwatch reporter, (b)(6), confirmed that there was no injury involved. The sepp broke in the act of being opened, resulting in pre-activation by the user. Although we have made several attempts, the customer has been unable to clarify exactly what "splintering" means, since the glass is supposed to be broken in order to release the antiseptic. It is unclear whether or not the sepp was actually defective or merely activated prematurely. Carefusion opened (b)(4) for the issue, and provided shipping instructions to the customer so that they could send the sample directly to carefusion for their evaluation, which is still in progress. Currently, we have no remaining inventory of the i. V. Start kit complaint lot or of the chloraprep sepp lots involved with this complaint and no further complaints for this lot.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1030451-2013-00008 |
| MDR Report Key | 3546323 |
| Report Source | 00,05 |
| Date Received | 2013-11-20 |
| Date Mfgr Received | 2013-10-24 |
| Device Manufacturer Date | 2013-01-01 |
| Date Added to Maude | 2014-01-22 |
| 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 | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEBORAH KLOOS, DIRECTOR |
| Manufacturer Street | 25 HEYWOOD RD. MINOR PROCEDURE KITS AND TRAYS SBU |
| Manufacturer City | ARDEN NC 28704 |
| Manufacturer Country | US |
| Manufacturer Postal | 28704 |
| Manufacturer Phone | 8286818820 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NONE |
| Generic Name | NONE |
| Product Code | LRS |
| Date Received | 2013-11-20 |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-11-20 |