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 2017-03-31 for CIDEX REGULAR 2266 manufactured by Advanced Sterilization Products.
[71479288]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[71479289]
A customer reported using cidex? Regular past the 14-day reuse period. The load was released and used on patients. There are no serious injuries reported. Per the instructions for use (ifu), it states cidex? Must be discarded after its 14-day reuse period even if the cidex? Test strip indicates a concentration above the minimum effective concentration (mec). The customer was advised to always follow the ifu. As a matter of policy, advanced sterilization products (asp) has decided to report cases where a customer used cidex? Regular beyond its 14-day reuse period.
Patient Sequence No: 1, Text Type: D, B5
[76528212]
Correction: there were no instruments used on patients. (b)(4). Asp investigation summary: the investigation included a review of the batch history record, complaint trending by lot number, system risk analysis (sra), visual analysis, supplier evaluation 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 a quality problem with no impact on safety 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 customer stated the loads were not recalled; however, no loads were used on patients since the issue occurred with a medical device manufacturer and not in a health care facility. The likely assignable cause of this issue was failure to follow instructions. The customer was advised to not use the solution past the 14-day reuse period. The issue will continue to be tracked and trended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2084725-2017-00161 |
| MDR Report Key | 6449815 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-03-31 |
| Date of Report | 2017-03-08 |
| Date of Event | 2017-03-08 |
| Date Mfgr Received | 2017-05-09 |
| Date Added to Maude | 2017-03-31 |
| 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 |
| Manufacturer G1 | ADVANCED STERILIZATION PRODUCTS |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92618 |
| 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 | 2017-03-31 |
| 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 | 2017-03-31 |