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

Catalog Number 6833

Device Problems Failure To Adhere Or Bond (1031); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/05/2012

Event Type  malfunction  

Event Description

Clamp came off of baby's cord.

Manufacturer Narrative

Investigation findings: initial investigation: no lot number or sample provided for investigation.Inventory was not checked as a visual inspection of the product would not reveal or detect the reported defect.Updated: a further review of the complaint has identified that the complaint will be required for updates.Deroyal regulatory department has been notified of the re-opening of the report.The sample was not returned and the lot number was not reported; therefore, it is unk as to if the product was of the previous design or the design that was implemented in 06/2012.The design change was implanted in 06/2012 and approved through (b)(4).Deroyal also evaluated the clamp compression force of the device through validation protocol (b)(4) - comparative testing of cord clamp compression force.Refer to the validation protocol (b)(4).The 2013, 2014, and 2015 qfi logs were reviewed utilizing the keyword "umbilical" to identify if customer complaints have been received for the raw material (b)(4) or finished goods that contain the raw material.There have been no complaints received during the review period.(b)(4).Correction: a correction has not been taken.Root cause analysis: initial investigation: undetermined, no lot number or sample was provided.Update: the true root cause for the reported issue is unable to be identified.Potential root causes have been identified but are not limited to the following: product defect; end user failing to follow the ifu and not ensuring the product was applied correctly and fully closed; and end user error failing to follow the ifu and cutting the umbilical cord too close to the cord clamp resulting in slippage.

• Brand Name: UMBILICAL CORD CLAMP
• Type of Device: DEVICE, OCCLUSION, UMBILICAL
• Manufacturer (Section D): DEROYAL INDUSTRIES; 700 martin luther king, jr. blvd.; sanford FL 32771
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8643622333
• MDR Report Key: 4732986
• MDR Text Key: 5742622
• Report Number: 1033554-2015-00003
• 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,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6833
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/05/2012
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/06/2012
• Initial Date FDA Received: 04/27/2015
• 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