MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-05-05 for UMBILICAL CORD CLAM, NS 6833NS manufactured by Deroyal Industries.
[20776536]
Clamp was difficult to close and then later released.
Patient Sequence No: 1, Text Type: D, B5
[20845708]
Investigation findings: deroyal is the mfr of finished good 6833ns, 89-6311, and 89-6310 identified by the customer. When the customer experienced the issue they could not provide the tray number in which the reported umbilical cord clamp was utilized out of. The report is described as "clamp was difficult to close and then later released". The qc complaint specialist contacted the customer on (b)(4) 2012 to obtain add'l info. It was started by the customer that "when it was trying to snap close it would not stay, would not stay shut. " the customer also did not know if the prod was fully closed and identified a possible end user error. The customer also indicated the sample is not available to be returned to deroyal for review. The raw material level as obtained for the umbilical cord clamp for each of the finished goods identified by the customer. Raw materials (b)(4) was obtained, but has multiple vendors listed within the jde operating sys. Without the lot info the vendor can not be identified. Correction: a correction action has not been taken. Root cause analysis: undetermined: the root cause could not be determined due to lack of info. Corrective action and/or systemic correction action taken: due to the root cause determination a corrective action has not been taken. Preventive action: due to the root cause determination a preventative action has not been taken. This report is being filed due to a retrospective review of complaints. This complaint has been reopened for further investigation. A supplemental report will be filed if further investigation provides info which changes the content of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1033554-2015-00013 |
| MDR Report Key | 4752176 |
| Report Source | 06 |
| Date Received | 2015-05-05 |
| Date of Report | 2015-05-01 |
| Date of Event | 2012-10-19 |
| Date Facility Aware | 2012-10-19 |
| Report Date | 2015-05-01 |
| Date Mfgr Received | 2012-10-19 |
| Date Added to Maude | 2015-06-15 |
| 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 LN |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653622333 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UMBILICAL CORD CLAM, NS |
| Generic Name | DEVICE, OCCLUSION, UMBILICAL |
| Product Code | FOD |
| Date Received | 2015-05-05 |
| Catalog Number | 6833NS |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES |
| Manufacturer Address | 700 MARTIN LUTHER KING JR BLVD SANFORD FL 32771 US 32771 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-05-05 |