MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-19 for CARDINAL PRESOURCE SUT21MBARD manufactured by Cardinal Health.
[78360912]
Patient Sequence No: 1, Text Type: N, H10
[78360913]
During setup of an operating room (or) procedure, the nurse/scrub tech opened a major basin set-up pack. The back table cover was removed to drape on the table. The drape was stuck to itself and would not unfold properly. Additionally there was a hole in the drape, possibly from trying to open the drape. Another pack was used without incident. No patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6650448 |
| MDR Report Key | 6650448 |
| Date Received | 2017-06-19 |
| Date of Report | 2017-06-15 |
| Date of Event | 2017-06-06 |
| Report Date | 2017-06-15 |
| Date Reported to FDA | 2017-06-15 |
| Date Reported to Mfgr | 2017-06-15 |
| Date Added to Maude | 2017-06-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDINAL PRESOURCE |
| Generic Name | STERILE MAJOR BASIN PACK |
| Product Code | FNY |
| Date Received | 2017-06-19 |
| Model Number | SUT21MBARD |
| Catalog Number | SUT21MBARD |
| Lot Number | 691768 |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1500 WAUKEGAN RD. WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-19 |