MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-16 for MEDI-VAC GUARDIAN RIGID SUCTION CANISTER SYSTEM 1200 CC RIGID CANISTER 65651-212 manufactured by Cardinal Health 200, Llc.
[40516811]
Patient Sequence No: 1, Text Type: N, H10
[40516812]
Within the past week we have had suction canisters to spontaneously crack at the top of the canister. This has occurred in multiple patient rooms. We have had about six do this so far and we are sending two to materials management to be inspected for product defect. The canisters that have cracked have been noted to be hooked to continuous high wall suction on two different types of suction gauges. When the canisters crack we lose suction (not all, but most). This can cause an issue if a patient has a chest tube hooked to wall suction or if the patient needs emergent airway clearing via suctioning and there is not appropriate suction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5503473 |
| MDR Report Key | 5503473 |
| Date Received | 2016-03-16 |
| Date of Report | 2016-03-07 |
| Date of Event | 2016-03-04 |
| Report Date | 2016-03-07 |
| Date Reported to FDA | 2016-03-07 |
| Date Reported to Mfgr | 2016-03-07 |
| Date Added to Maude | 2016-03-16 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDI-VAC GUARDIAN RIGID SUCTION CANISTER SYSTEM |
| Generic Name | VACUUM POWERED BODY FLUID COLLECTION KIT |
| Product Code | OJR |
| Date Received | 2016-03-16 |
| Model Number | 1200 CC RIGID CANISTER |
| Catalog Number | 65651-212 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 785 FORT MILL HIGHWAY FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-16 |