MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-09-18 for CARDINAL CUSTOM C-SECTION KIT SRHPG23CSA01 * manufactured by Cardinal Health.
[2882208]
The nurse opened the custom c-section delivery pack and found the infant/family arm bands loose inside the kit. 2 pair of bands matched instead of all four. The numbers need to match in order for the infant to be given to the correct family. This is the second occurrence that we have identified. ======================manufacturer response for infant and family id bands in a c- section pack, cardinal (per site reporter). ======================the manufacturer is very apologetic and alarmed. The sales rep sent in a whole case of new armbands so nursing can discard any more miss-matched bands. Cardinal has committed to following up on the failure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2749373 |
| MDR Report Key | 2749373 |
| Date Received | 2012-09-18 |
| Date of Report | 2012-09-18 |
| Date of Event | 2012-08-29 |
| Report Date | 2012-09-18 |
| Date Reported to FDA | 2012-09-18 |
| Date Added to Maude | 2012-09-18 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDINAL CUSTOM C-SECTION KIT |
| Generic Name | CESAREAN SECTION KIT, ID BANDS |
| Product Code | OHM |
| Date Received | 2012-09-18 |
| Model Number | SRHPG23CSA01 |
| Catalog Number | * |
| Lot Number | 152213 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH |
| Manufacturer Address | 1430 WAUKEGAN RD. MCGAW PARK IL 60085 US 60085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-09-18 |