MAUDE Adverse Event Report: DEROYAL INDUSTRIES C-SECTION TRAY; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number 50-13004

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2012

Event Type  malfunction  

Event Description

Umbilical cord clamp in c-section cpt did not clamp all the way and another clamp was pulled separately.

Manufacturer Narrative

Investigation findings: the customer was contacted on 10/30/2012.A lot number is not available and neither is the actual sample for the report.Due to the lack of info, a thorough investigation cannot be performed.Correction: credit was issued.Root cause analysis: undetermined, no sample or lot number provided.Corrective action and/or systemic correction action taken: none taken.Preventive action: none taken.This report is being filed due to a retrospective review of complaints.This complaint has been re-opened for further investigation.A supplemental report will be filed if further investigation provides info which changes the content of this report.

• Brand Name: C-SECTION TRAY
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• 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: 4752175
• MDR Text Key: 5826624
• Report Number: 1033554-2015-00014
• 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: 50-13004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2012
• 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