MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL DISPOSABLE NEONATAL BLOOD PRESSURE CUFF

Catalog Number 71-3103

Device Problems Material Integrity Problem (2978); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/01/2015

Event Type  malfunction  

Event Description

New blood pressure cuff retrieved for newly admitted patient.Cuff broke to where tubing inserts to cuff on 3rd use.Has to be changed very frequently.

Manufacturer Narrative

Investigation findings: the qfi report was reviewed for sales and similar complaint information.Deroyal has sold (b)(4) cases of the finished good from 2013 to present.Similar complaints have been received in 2015 for the product leaking.The finished good contains raw material (b)(4), which is supplied to deroyal by a contract manufacturer, (b)(4).The 2013-2015 scar/supplier notification logs were reviewed and previous vendor notifications identified.(b)(4) was issued to (b)(4).During a conference call on 07/15/2015 with (b)(4) and deroyal personnel, it was determined the scar would be accepted and closed using a previous response with additional documentation detailing actions taken.Deroyal supply chain has provided approval for the contract manufacturer to implement a material modification to the nipple connecting the tubing to the cuff.Implementation dates have been provided for the affected part numbers.Deroyal will continue to track and trend for the reported issue and will recognize in the future if the issue becomes recurring after implementation of the material change.Correction: a correction has not been taken.Root cause analysis: scar: the reported issue was determined to be a vendor subcontractor nipple supplier quality issue.Corrective action and/or systemic correction action taken: scar: (b)(4) has developed a new nipple that is ready for production.It is identical to the current nipple except it's produced with a new mold and compound.(b)(4) testing results have identified that the new nipple performs better and is more robust.Evidence of the testing performed by (b)(4) is included within the scar response.Deroyal: (b)(4) has supplied representative samples of the current product and product with the proposed modification.These samples were provided to deroyal supply chain and engineering for evaluation and approval for the proposed changes.The vendor's test methods were provided with the representative samples.Deroyal initiated independent testing and evaluation of the product.This testing and the conclusions are documented within the corp.Pcl-060 - neonatal blood pressure attachment.Based upon engineering's data and evaluation, deroyal supply chain approved the new nipple material.Evidence of this approval is contained within the supply chain memo in the scar attachment.(b)(4) has provided implementation dates for this material change.(b)(4) has provided implementation dates and testing criteria to deroyal.The product has been placed under a 100 percent inspection process of the existing raw material inventory to determine if the product can be utilized in deroyal's production process.Product that does not conform to the vendor outlined testing criteria will be quarantined and returned to (b)(4) for replacement product utilizing the new nipple.Evidence of this approval is in the supply chain memo in the scar attachment.Preventive action: scar: change to the new nipple.Deroyal: deroyal has provided approval to (b)(4) to change to the new material.Evidence of the approval and implementation dates for each part number are included within the supply chain memo contained within the scar response.This investigation is complete.No further information is available at this time.

• Brand Name: DISPOSABLE NEONATAL BLOOD PRESSURE CUFF
• Type of Device: BLOOD PRESSURE CUFF
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL; km 7m autopista joaquin aalaguer; pisano free zone, bldg 49; santiago ; DR
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 4927993
• MDR Text Key: 6431071
• Report Number: 3004605321-2015-00014
• Device Sequence Number: 1
• Product Code: DXQ
• Combination Product (y/n): N
• PMA/PMN Number: K991525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 71-3103
• Device Lot Number: NP
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/02/2015
• Distributor Facility Aware Date: 03/01/2015
• Event Location: Hospital
• Date Manufacturer Received: 06/16/2015
• 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
• Type of Device Usage: Initial
• Patient Sequence Number: 1