MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-20 for CARDINAL HEALTH SMA56DBIHF manufactured by Cardinal Health 200, Llc.
[184276910]
Anesthesia monitoring tech opened the "pack ob vag del basin ihc" pack for an ob vaginal delivery and it was missing the pack of sponges. Normally there are 5 sponges packaged in the pack. The tech obtained an additional pack of sponges to add to the delivery table to use with the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9859763 |
| MDR Report Key | 9859763 |
| Date Received | 2020-03-20 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-03-02 |
| Report Date | 2020-03-03 |
| Date Reported to FDA | 2020-03-03 |
| Date Reported to Mfgr | 2020-03-20 |
| Date Added to Maude | 2020-03-20 |
| 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 |
| 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 | LABOR AND DELIVERY KIT |
| Product Code | MLS |
| Date Received | 2020-03-20 |
| Model Number | SMA56DBIHF |
| Catalog Number | SMA56DBIHF |
| Lot Number | 352908 |
| Device Availability | N |
| Device Age | 3 MO |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH 200, LLC |
| Manufacturer Address | 785 FORT MILL HWY. FORT MILL SC 29707 US 29707 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-20 |