MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-08-14 for UMBILICUP CORD BLOOD COLLECTION DEVICE 72-8000 manufactured by Deroyal Industries, Inc..
[25394400]
(b)(4). This report was determined to be an isolated event after the implementation of mkmi medical innovations' corrective actions. Deroyal will continue to monitor trends for this failure and will recognize in the future if it transitions into a recurring issue. Correction: a credit was provided. Root cause analysis: the reported issue was determined to be a failure due to a vendor supplied item. Deroyal assembly personnel failed to visually detect the missing needle during the packaging process.
Patient Sequence No: 1, Text Type: N, H10
[25394401]
Staff in l and d operating room noticed there was not a needle in the umbilicup when they tried to insert the collection tube to collect cord blood. The absence of the needle had not been noticed prior to that time. A needle was not found in the ldor while an x-ray was taken and read to be sure the needle was not present. The entire ldor floor was checked prior to case breakdown.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2015-00040 |
| MDR Report Key | 5010420 |
| Report Source | USER FACILITY |
| Date Received | 2015-08-14 |
| Date of Report | 2015-08-12 |
| Date of Event | 2015-07-05 |
| Date Mfgr Received | 2015-07-14 |
| Device Manufacturer Date | 2013-09-01 |
| Date Added to Maude | 2015-08-18 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UMBILICUP CORD BLOOD COLLECTION DEVICE |
| Generic Name | CONTAINER, EMPTY, FOR COLLECTION |
| Product Code | KSR |
| Date Received | 2015-08-14 |
| Catalog Number | 72-8000 |
| Lot Number | 33170639 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 700 MARTIN LUTHER KING, JR. BLVD. SANFORD FL 32771 US 32771 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-08-14 |