MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-15 for NEONATAL BLOOD COLLECTION KIT AND SCREENING FORM manufactured by Americord.
[92313993]
Fetal cord blood collection kit (americord) has incorrect packaging for use during surgery (cesarean section). If product is used as directed, you are pulling a sterile cord blood collection bag through a torn (non-sterile) opening, which makes it virtually impossible to maintain sterility when passing onto the sterile field. Mothers are being put at risk of a surgical site infection if this product is used.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5073369 |
| MDR Report Key | 7037466 |
| Date Received | 2017-11-15 |
| Date of Report | 2017-11-13 |
| Date of Event | 2017-11-13 |
| Date Added to Maude | 2017-11-16 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | NEONATAL BLOOD COLLECTION KIT AND SCREENING FORM |
| Generic Name | BLOOD COLLECTION KIT |
| Product Code | OIA |
| Date Received | 2017-11-15 |
| Device Availability | * |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AMERICORD |
| Manufacturer Address | 139 FULTON ST STE 707 NEW YORK NY 10038 US 10038 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-11-15 |