MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2012-06-21 for SHUR-CLENS - WOUND CLEANSER 121222 manufactured by Convatec.
[21021031]
Stated problem: don called to report that a respiratory therapist accidentally instilled a 20 ml vial of shurclens into an et tube during a code situation. There was foaming of solution in et tube so it was suctioned and irrigated multiple times before pt transferred. This is a critical access hospital so pt was immediately transferred out to (b)(6). From a clinical perspective, the event occurred in the emergency room whilst pt was in respiratory arrest and was intubated. A respiratory therapist accidentally grabbed the ampoule of shurclens instead of the ampule of normal saline and instilled 20 mls into the et tube. There was foaming in the et tube and it was suctioned and irrigated. Pt's current condition is unk, as she was immediately transferred to another hospital as part of her pre-planned care not related to this event. This ae is deemed serious because of the possibility of pt suffering aspiration or chemical pneumonitis from the product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2243969-2012-00038 |
| MDR Report Key | 2633754 |
| Report Source | 05,06,07 |
| Date Received | 2012-06-21 |
| Date of Report | 2012-05-25 |
| Date of Event | 2012-05-25 |
| Date Mfgr Received | 2012-05-25 |
| Date Added to Maude | 2012-07-05 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ADRIENNE MCNALLY |
| Manufacturer Street | 200 HEADQUARTERS PARK DR. |
| Manufacturer City | SKILLMAN NJ 08558 |
| Manufacturer Country | US |
| Manufacturer Postal | 08558 |
| Manufacturer Phone | 9089042630 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SHUR-CLENS - WOUND CLEANSER |
| Generic Name | SHUR CLENS WOUND CLEANSER |
| Product Code | KOY |
| Date Received | 2012-06-21 |
| Model Number | NA |
| Catalog Number | 121222 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONVATEC |
| Manufacturer Address | 200 HEADQUARTERS PARK DR. SKILLMAN NJ 08558 US 08558 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2012-06-21 |