MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2007-08-23 for ALLEGIANCE ADULT/INFANT ID WRISTBAND SET * 10119-055A manufactured by Cardinal Health Medical Products And Services.
[675463]
The allegiance brand identification wristbands set for mother, father, and infant do not match. The printed id numbers should all match on each band, however, it was discovered that all numbers are out of sequence and do not match. This error has serious ramifications as it poses the threat of mother and infant being mismatched. Existing policies on band wrist ids have been reinforced and our entire healthcare system has been placed on alert. At this time appropriate replacement vendors are being considered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 904822 |
| MDR Report Key | 904822 |
| Date Received | 2007-08-23 |
| Date of Report | 2007-08-23 |
| Date of Event | 2007-08-23 |
| Report Date | 2007-08-23 |
| Date Reported to FDA | 2007-08-23 |
| Date Added to Maude | 2007-08-30 |
| 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 | ALLEGIANCE ADULT/INFANT ID WRISTBAND SET |
| Generic Name | ID BRACELET, ADULT AND INFANT |
| Product Code | LDQ |
| Date Received | 2007-08-23 |
| Model Number | * |
| Catalog Number | 10119-055A |
| Lot Number | 06-2200-1 |
| ID Number | * |
| Device Availability | Y |
| Device Age | 1 DY |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 879656 |
| Manufacturer | CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES |
| Manufacturer Address | 1430 WAUKEGAN ROAD MCGAW PARK IL 600856787 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-23 |