MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2012-08-23 for CARDINAL HEALTH HYBRID PACK SRHPG23CSA01 manufactured by Cardinal Health, Inc..
[2795107]
The nurse opened the custom c-section delivery pack and found the infant/family arm bands loose inside the kit. All four of the armband numbers were different which is a potential safety risk. The numbers need to match in order for the infant to be given to the correct family. This is the first occurrence that we have identified. Because the bands are sequenced in sets of four and we received four different numbers, there could be at least four other packs affected. However, so far we have not seen anymore occurrences. The l&d department is aware and checking the bands for accuracy. ======================manufacturer response for id bands/custom c-section delivery pack, cardinal health hybrid pack (per site reporter). ======================that is definitely not acceptable. Thanks for alerting me. I am forwarding and investigating. You will be contacted again. This is a high alert. We'll need a quick response and follow up. The bracelets are used for identification, and this is a safety issue. Please forward now and ask for a quick response along with a follow up letter.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2713000 |
| MDR Report Key | 2713000 |
| Date Received | 2012-08-23 |
| Date of Report | 2012-08-23 |
| Date of Event | 2012-08-22 |
| Report Date | 2012-08-23 |
| Date Reported to FDA | 2012-08-23 |
| Date Added to Maude | 2012-08-24 |
| 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 | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARDINAL HEALTH HYBRID PACK |
| Generic Name | ID BANDS/CUSTOM C-SECTION DELIVERY PACK |
| Product Code | OHM |
| Date Received | 2012-08-23 |
| Model Number | SRHPG23CSA01 |
| Catalog Number | SRHPG23CSA01 |
| Lot Number | 152213 |
| ID Number | * |
| Operator | NURSE |
| Device Availability | Y |
| Device Age | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDINAL HEALTH, INC. |
| Manufacturer Address | 1320 DON HASKINS SUITE A EL PASO TX 79936 US 79936 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-08-23 |