MAUDE Adverse Event Report: VINCENT MEDICAL 90043164 2133 CORD CLAMP CLIPPER 1 EA

Model Number 52000008

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemorrhage/Bleeding (1888); Laceration(s) (1946)

Event Date 01/18/2015

Event Type  Injury  

Event Description

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.

Manufacturer Narrative

Submit date: 3/11/2015.An investigation is currently underway.Upon completion, the results will be forwarded.(b)(4).

Manufacturer Narrative

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.

Manufacturer Narrative

The submit date on the initial report was inadvertently listed as (b)(6) 2015 and should be (b)(6) 2015.

• Brand Name: 90043164 2133 CORD CLAMP CLIPPER 1 EA
• Type of Device: CORD CLAMP CLIPPER
• Manufacturer (Section D): VINCENT MEDICAL; 22 talega; santa margarita CA 92688
• Manufacturer (Section G): VINCENT MEDICAL; 22 talega; rancho santa margarita CA 18015
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4587882
• MDR Text Key: 5448502
• Report Number: 1282497-2015-00014
• Device Sequence Number: 1
• Product Code: HDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 52000008
• Device Catalogue Number: 52000008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 DA