MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-05 for UMBILICUP 72-8000NS manufactured by Deroyal Intercontinental, S.r.l..
[124145617]
Root cause: the true root cause cannot be determined at this time due to the lack of a sample for evaluation. Potential root causes have been identified but are not limited to the following: an end use error or an event isolated to a single reporting customer. The product's instructions for use includes a warning that "care should be exercised whenever handling sharp needles to prevent accidental needle sticks. " corrective action: due to the investigation and root cause determination, a corrective action has not been identified as being necessary. Investigation summary: an internal complaint ((b)(4)) was received indicating the needle of an umbilicup (part 72-8000ns, lot unknown) pricked a healthcare provider. The sample was not returned for evaluation because the product was discarded by the end user due to contamination. Additionally, a lot number was not provided by the end user. Therefore, the complaint investigator was unable to review the work order for discrepancies that may have contributed to the reported event. Deroyal has sold (b)(4) cases of the finished good from october 4, 2017 to september 5, 2018. Each case contains (b)(4) eaches, which equates to (b)(4) eaches sold. A review of complaints for the same time period yielded no similar issues reported. This results in a complaint-to-sales ratio of (b)(4) percent. Deroyal will continue to monitor post-market feedback and will recognize in the future if this issue reoccurs. Preventive action: due to the investigation and root cause determination, a preventive action has not been taken. The investigation is complete at this time. If new and critical information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[124145618]
Healthcare provider was pricked by the needle under the gray rubber.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1060680-2018-00008 |
| MDR Report Key | 7939127 |
| Date Received | 2018-10-05 |
| Date of Report | 2018-10-05 |
| Date of Event | 2018-09-05 |
| Date Mfgr Received | 2018-09-05 |
| Date Added to Maude | 2018-10-05 |
| 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 Contact | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL LINDUSTRIES, INC. |
| Manufacturer Street | 1703 HIGHWAY 33 SOUTH |
| Manufacturer City | NEW TAZEWELL TN 37825 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37825 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | UMBILICUP |
| Generic Name | CONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS |
| Product Code | KSR |
| Date Received | 2018-10-05 |
| Model Number | 72-8000NS |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INTERCONTINENTAL, S.R.L. |
| Manufacturer Address | KM 7, AUTOPISTA JOAQUIN BALAGU PISANO FREE ZONE, BUILDING 49 SANTIAGO, SANTIAGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-05 |