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

Catalog Number 6833NS

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 01/05/2012

Event Type  malfunction  

Event Description

Customer stated they received several clamps that appear to be defective (clamps won't stay shut, after initial clamping).

Manufacturer Narrative

Investigation findings: deroyal has sold (b)(4) cases of product 6833ns; which has a report of the "several clamps that appear to be defective clamps won't stay shut after initial clamping".The samples are not available for the product.Catalog information is available.See attached.The call history logs were reviewed for similar complaints.No similar complaints have been received.The vendor was issued a scar on 1/9/2012.Follow up dates were noted within the scar log as 1/22/2012 and 1/31/2012.On 1/31/2012 the vendor requested additional time.The vendor issued a response on (b)(4) 2012.For additional investigation findings please refer to the attached car response.Correction (action taken to correct the issue and contain the problem): a correction has not been made at the present time.Root cause analysis: the lot history record for the reference lot was reviewed and it was confirmed that the lots met all specifications prior to release.Given the part in question was not returned for evaluation, it is not possible to perform an in depth investigation.As due diligence, an inventory verification was performed and it was identified that no product remained on hand for this lot.A recent study conducted by engineering, where cord clamps where submitted to a series of tests reveals that "during testing, no failures were observed of either the latching mechanism or hinge." given that a sample was not submitted for evaluation, it is not possible to determine the cause of the reported incident.Updated: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 during the manufacturing process; 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 of the clamp.Corrective action and/or systemic correction action taken: refer to the attached car response.Updated: as a result of an engineering study, an opportunity was identified.The main improvement was identified.The main improvement was having more curve to the tooth profile.It was decreased from a radius of 19.1 inches to a radius of 11 inches.This adds to the closing force and keeps more pressure in the center of the clamp.The secondary change was adding about.015 inches of added height to the back rid.This should make the clamp have a slightly higher closing force.The first lot number manufactured after the changes have been identified as lot 12061431.Preventive action- refer to the attached car response.Updated: due to the investigation and root cause determination a preventive action has not been 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 information which changes the content of this report.

• Brand Name: UMBILICAL CORD CLAMP, NON-STERILE
• 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 ; 8653622333
• MDR Report Key: 4749184
• MDR Text Key: 5823556
• Report Number: 1033554-2015-00004
• 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: Other
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 6833NS
• Device Lot Number: 26945096
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/05/2012
• Event Location: Hospital
• Date Manufacturer Received: 01/05/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2011
• 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