MAUDE Adverse Event Report: DEROYAL INDUSTRIES UMBILICAL CORD CLAM, NS; DEVICE, OCCLUSION, UMBILICAL

Catalog Number 6833NS

Device Problems Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2012

Event Type  malfunction  

Event Description

Clamp was difficult to close and then later released.

Manufacturer Narrative

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.

• Brand Name: UMBILICAL CORD CLAM, NS
• Type of Device: DEVICE, OCCLUSION, UMBILICAL
• Manufacturer (Section D): DEROYAL INDUSTRIES; 700 martin luther king jr blvd; sanford FL 32771
• Manufacturer Contact: 200 debusk ln; powell, TN 37849 ; 8653622333
• MDR Report Key: 4752176
• MDR Text Key: 20776536
• Report Number: 1033554-2015-00013
• Device Sequence Number: 1
• Product Code: FOD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6833NS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/19/2012
• Event Location: Hospital
• Date Manufacturer Received: 10/19/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention