MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2016-10-11 for CIDEX REGULAR 2266 manufactured by Advanced Sterilization Products.
[57109334]
A customer called to inquire about proper instructions for use (ifu) with their cidex? Activated dialdehyde solution. The customer stated they have been soaking their instruments for 5 minutes in the solution. They also stated they do not use test their cidex? Activated dialdehyde solution prior to use. There were no reported serious injuries reported with this event. The customer was informed the cidex? Activated dialdehyde solution must be tested prior to each use with cidex? Solution test strips, and the soaking time is 45 minutes. The customer was advised to always follow the ifu. Although no prior incidents have resulted in serious injury, asp has determined that in this situation, sterility or high level disinfection cannot be assured. Therefore asp has decided to report all incidents as a matter of policy.
Patient Sequence No: 1, Text Type: D, B5
[60539751]
(b)(4). Asp investigation summary: the investigation included a review of the batch history record, complaint trending, system risk analysis (sra), visual analysis, functional analysis and retains analysis. ? The batch history record could not be reviewed as the lot number was not available. ? Complaint trending could not be performed as the lot number was not available. ? The sra indicates the risk associated with exposure to biohazardous, pathogenic or infectious material is "low. "? Visual analysis was not performed as the product was not available for return. ? The supplier was not notified of the issue as the issue was not identified as a manufacturing or functional issue. ? Retains testing was not performed as the lot number was not available. The assignable cause of this issue was failure to follow instructions. The customer was sent the instructions for use (ifu). Upon further follow-up, the customer stated they are no longer using the product. The issue will continue to be tracked and trended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2084725-2016-00595 |
| MDR Report Key | 6019289 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2016-10-11 |
| Date of Report | 2016-09-15 |
| Date of Event | 2016-09-15 |
| Date Mfgr Received | 2016-11-09 |
| Date Added to Maude | 2016-10-11 |
| 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 | JOAQUIN KURZ |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 9497893837 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CIDEX REGULAR |
| Generic Name | BIOCIDES SOLUTIONS (LRJ) |
| Product Code | LRJ |
| Date Received | 2016-10-11 |
| Catalog Number | 2266 |
| Lot Number | UNK |
| ID Number | 2266 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Address | 33 TECHNOLOGY DRIVE IRVINE CA 92618 US 92618 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-11 |