MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-03 for CARDINAL HEALTH SAN34HCBHF manufactured by Cardinal Health 200, Llc.
[177374777]
During the procedure, half-way through, dr. Noticed a blue cloth-like piece floating in the sterile bowl of heparinized saline. Verbalized with team and all in the room the risk for safety of the patient and the potential event that could be caused by the towel shedding. The bowl was then presented to leadership and then replaced with a new bowl and with new fluids. Case proceeded as normal and with no other issues from this standpoint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9659280 |
| MDR Report Key | 9659280 |
| Date Received | 2020-02-03 |
| Date of Report | 2019-10-30 |
| Date of Event | 2019-10-16 |
| Report Date | 2019-10-30 |
| Date Reported to FDA | 2019-10-30 |
| Date Reported to Mfgr | 2020-02-03 |
| Date Added to Maude | 2020-02-03 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 HEALTH |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2020-02-03 |
| Catalog Number | SAN34HCBHF |
| Lot Number | 265894 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 3651 BIRCHWOOD DRIVE WAUKEGAN IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-03 |