MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-11-05 for I-RIGID OUTER SUCTION CANISTER OR531 manufactured by Medline.
[30881923]
Pt on operating room table for scheduled acl. The pt was draped. Surgical tech passed off suction to drape. Circulation rn attached suction and turned it on. After a couple of minutes, there was a loud "popping" noise and suction canister exploded. The bottom piece of the outer canister flew across the room and hit the surgical tech in the chest, then hit the sterile drapes, which were then contaminated. The piece which broke off was very sharp and could have caused serious injury. Issue at hand involved medline's 3000cc semi rigid outer canister (product # or531) and accompanying suction canister semi rigid liner (product #or530). The suction canister literally exploded in the operating room and could have caused significant injury to both staff and our pt. Fortunately, that was not the case, however we're reporting this to avoid potential injury to anyone else. Diagnosis or reason for use: used to collect fluid during surgery, collects fluid during surgical procedures. Event abated after use stopped or dose reduced: yes.
Patient Sequence No: 0, Text Type: D, B5
| Report Number | MW5057767 |
| MDR Report Key | 5213949 |
| Date Received | 2015-11-05 |
| Date of Report | 2015-11-05 |
| Date of Event | 2015-10-21 |
| Date Added to Maude | 2015-11-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 | I-RIGID OUTER SUCTION CANISTER |
| Generic Name | I-RIGID OUTER SUCTION CANISTER |
| Product Code | KDQ |
| Date Received | 2015-11-05 |
| Model Number | OR531 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | DANBURY CT 06810 US 06810 |
| Brand Name | SUCTION CANISTER SEMI RIGID LINER |
| Generic Name | SUCTION CANISTER SEMI RIGID LINER |
| Product Code | DWD |
| Date Received | 2015-11-05 |
| Model Number | OR530 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE |
| Manufacturer Address | DANBURY CT 06810 US 06810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Other | 2015-11-05 |