MAUDE Adverse Event Report: DEROYAL INDUSTRIES UMBILICAL CORD CLAMP

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 06/05/2012

Event Type  malfunction  

Event Description

When the clamp was placed on the baby the clamp slid off.Product purchased from professional hospital supply in a kit.Lot was not known.

Manufacturer Narrative

Investigation findings: initial investigation: deroyal is the mfr of finished good 6833, 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 06/12/2012, 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 (b)(4).Determined the vendor was (b)(4).A car was issued on 06/14/2012.The vendor issued the completed car on 08/06/2012.In addition, the qc complaint specialist reviewed the 2010, 2011, and 2012 sales info 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.Deroyal regulatory department has been notified of the re-opening of the report; the sample was returned to deroyal and provided to (b)(4) for eval.This info is documented within the sample retrieval process of the initial complaint investigation worksheet; due to receiving (b)(4) during the investigation process of (b)(4) and had the same failure mode; therefore, (b)(4) was notified of the new event.The additional report, (b)(4), contained a lot number (the lot number was not identified for call (b)(4)); lot info was added to the deroyal plastics group problem analysis report and car response that was completed for call (b)(4); within the car response it is detailed that a design change was implemented 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); in addition, 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.

• Brand Name: UMBILICAL CORD CLAMP
• 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: 4732988
• MDR Text Key: 5749353
• Report Number: 1033554-2015-00001
• 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: 04/21/2015

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?: Yes
• Date Returned to Manufacturer: 07/09/2012
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/05/2012
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/11/2012
• Initial Date FDA Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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