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

Catalog Number 6833

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2012

Event Type  malfunction  

Event Description

(b)(6) has gotten switched to the deroyal umbilical cord clamps and they are having issues.Clamps are sliding off, they are having to double clamp the umbilicus.They said staff are commenting that the deroyal clamp does not have the tension that their previous clamp provided.

Manufacturer Narrative

Investigation findings: initial investigation of call (b)(4) in which the call was identified as being a memo to: deroyal is the manufacturer of finished good (b)(4), umbilical cord clamp, which has a report of "when the clamp was placed on the baby the clamp slid off." the bom was reviewed, on 6/12/2012, and raw material (b)(4) was identified.The raw material is a vendor supplied product.Confirmation on vendor needed prior to a scar being issued.Due to multiple vendors listed in the jde operating system the qc complaint specialist requested assistance from the qc to identify the vendor.The qc reviewed the past products received in bp 34.Determined the vendor was (b)(4).A car was issued on 6/14/2012.The vendor issued the completed car on 8/6/2012.In addition, the qc complaint specialist reviewed the 2010, 2011, and 2012 sales information and call history logs.Deroyal has sold (b)(4) each of raw material (b)(4), umbilical cord clamps.The call history log review found similar reports.Updated: a further review of the complaint has identified that the complaint will be required for updates.The call was not previously identified as a q6.During the evaluation of the complaint a request was received from deroyal regulatory to transition the call to q6 status upon re-opening.The initial investigation of the reported issue identified that the complaint was identified as a memo to call (b)(4).The previous investigation findings for call (b)(4) are contained within this worksheet and the (b)(4) complaint file.A car was issued to (b)(4) to address the issue of umbilical cord clamp slippage issues.Within the car response it is detailed that a design change was implemented in 6/2012 and approved through (b)(4).The first lot number produced after the implemented changes was identified as lot number 12061431.Since the reporting customer provided finished good lot number, 27729862, it was confirmed that the manufacturing date was prior to the implemented changes the actions taken as a result of the car response would be acceptable in addressing this report.In addition, lot mapping was performed and identified raw material (b)(4) lot number 11070531 as being contained within the finished good.De royal also evaluated the clamp compression force of the device through validation protocol (b)(4): comparative testing of cord clamp compression force.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.Deroyal utilizes raw material (b)(4) within multiple product lines and multiple branch plants.Refer to the products using (b)(4) sales in selling attachment for a listing and sales information of components that contain the finished good.Correction: a correction has not been taken.Root cause analysis: initial investigation of call (b)(4) in which the call was identified as being a memo to: evaluation results/root cause deroyal plastics group: the lot history record for the referenced lots was reviewed and it was confirmed that the lots met all specifications prior to release.As due diligence, and inventory verification was performed and it was identified that no product remained on hand for these lots.A recent study conducted by engineering, where cord clamps were submitted to a series of test reveals that "during testing, no failures were observed of either the latching mechanism or hinge." 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: initial investigation of call (b)(4) in which the call was identified as being a memo to.Updated: as a result of an engineering study, an opportunity 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: initial investigation of call (b)(4) in which the call was identified as being a memo to.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
• 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: 4749183
• MDR Text Key: 5770872
• Report Number: 1033554-2015-00007
• 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: 04/21/2015,04/30/2015

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: 03/29/2017
• Device Catalogue Number: 6833
• Device Lot Number: 28843721
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/23/2012
• Event Location: Hospital
• Date Manufacturer Received: 08/23/2012
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2012
• 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