MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,other report with the FDA on 2015-03-10 for 90043164 2133 CORD CLAMP CLIPPER 1 EA 52000008 manufactured by Vincent Medical.
[5448502]
Per the medwatch report received 02/23/2015, the nurse was assessing baby and identified bleeding from the baby's right hand, pinky finger. Prior to the nurse observing bleeding finger, the nurse had used the cord clamp cutter to remove the cord clamp. The infant's hands were not near the cord clamp cutter blade when the nurse was removing the cord clamp. It is believed that the pinky may have come in contact with the hinge of the device causing the laceration. Pressure was immediately applied and the physician was notified. The wound was irrigated and dressed. Orthopedics consulted and closed wound with histoacryl. Finger remained warm, pink, and newborn was able to move spontaneously. Newborn was discharged the following afternoon as planned with scheduled follow-up appointment with the orthopedic physician.
Patient Sequence No: 1, Text Type: D, B5
[12989744]
Submit date: 3/11/2015. An investigation is currently underway. Upon completion, the results will be forwarded. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[28073115]
Samples were not received for the investigation. A device history record review could not be performed because a lot number was not received with the complaint. As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product. Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the defect and root cause analysis. The most probable root cause could be misuse during hospital such as inadvertently scratch to the finger. A corrective action is not applicable at this time. Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures. This complaint will be used for qa tracking and trending purposes.
Patient Sequence No: 1, Text Type: N, H10
[34212162]
The submit date on the initial report was inadvertently listed as (b)(6) 2015 and should be (b)(6) 2015.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1282497-2015-00014 |
| MDR Report Key | 4587882 |
| Report Source | 00,OTHER |
| Date Received | 2015-03-10 |
| Date of Report | 2015-02-23 |
| Date of Event | 2015-01-18 |
| Date Mfgr Received | 2015-10-12 |
| Date Added to Maude | 2015-03-11 |
| 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 | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | VINCENT MEDICAL |
| Manufacturer Street | 22 TALEGA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 18015 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 18015 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 90043164 2133 CORD CLAMP CLIPPER 1 EA |
| Generic Name | CORD CLAMP CLIPPER |
| Product Code | HDJ |
| Date Received | 2015-03-10 |
| Model Number | 52000008 |
| Catalog Number | 52000008 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VINCENT MEDICAL |
| Manufacturer Address | 22 TALEGA SANTA MARGARITA CA 92688 US 92688 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-03-10 |