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 2019-04-08 for CIDEX? OPA SOLUTION 20390 manufactured by Advanced Sterilization Products.
[141322860]
Asp complaint ref #: (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[141322861]
A customer reported they are using cidex? Opa solution to manually clean and high-level disinfect their endoscopes and may not be properly rinsing the scopes according to the instructions for use (ifu). There are no serious injuries reported. The customer stated after cleaning and high-level disinfecting with cidex? Opa solution, their scopes are then removed from the solution and are rinsed by completely immersing in sterile water for 5 minutes and rinsed one time only. Per cidex? Opa ifu:? Keep the device totally immersed for a minimum of 1 minute in duration? And? Three (3) separate, large volume water immersion rinses are required". In this event, there were no reports of patients affected from improperly rinsed devices; however, the customer was not following the ifu and only rinsed the scopes one time instead of three. As a matter of policy, asp has decided to report cases when there is patient contact with a medical instrument that was not cleaned or rinsed properly per the cidex? Opa solution. The customer will be re-trained to follow the ifu for proper rinsing of their devices after use with cidex? Opa solution.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2084725-2019-00855 |
| MDR Report Key | 8494024 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-04-08 |
| Date of Report | 2019-03-20 |
| Date of Event | 2019-03-20 |
| Date Mfgr Received | 2019-06-07 |
| Date Added to Maude | 2019-04-08 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. GABRIELA MCLELLAN |
| Manufacturer Street | 33 TECHNOLOGY DRIVE |
| Manufacturer City | IRVINE CA 92618 |
| Manufacturer Country | US |
| Manufacturer Postal | 92618 |
| Manufacturer Phone | 949453-639 |
| 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? OPA SOLUTION |
| Generic Name | BIOCIDES SOLUTIONS |
| Product Code | MED |
| Date Received | 2019-04-08 |
| Catalog Number | 20390 |
| 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 | 2019-04-08 |