MAUDE Adverse Event Report: DEROYAL INDUSTRIES INC HEART/CV PACK CSM; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number 89-6900

Device Problems Material Frayed (1262); Material Deformation (2976); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2015

Event Type  malfunction  

Event Description

The length of delay was around 5-10 minutes.The surgeon is completely dissatisfied with the quality of the lap sponges that are in the deroyal csm heart packs.They are "fuzzy" and clinically unacceptable due to the lint that gets everywhere.The doctor ordered them removed from the room and open separate sterile laps to finish his case.

Manufacturer Narrative

Investigation findings: the product is supplied to deroyal by (b)(4).A scar has been issued and the (b)(4) due date identified as 06/05/2015.The qc complaint specialist followed up with the vendor in reference to the outstanding scar on 06/09/2015.Investigation is incomplete at this time.A f/u report will be completed with more info becomes available.

Manufacturer Narrative

Investigation findings: the work order was reviewed for discrepancies that would have contributed to the reported issue.No discrepancies were identified.(b)(4).Implementation of a processing sheet where the program in the machine has to match the mfg order and the product code improvements were verified since lot number 24-15.Preventive action, scar: a preventive action has not been taken.

Event Description

The length of delay was around 5-10 minutes.The surgeon is completely dissatisfied with the quality of the lap sponges that are in the deroyal csm heart packs.They are "fuzzy" and clinically unacceptable due to the lint that gets everywhere! the doctor ordered them removed from the room and open separate sterile laps to finish his case.

• Brand Name: HEART/CV PACK CSM
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES INC; 1501 east central ave.; lafollette TN 37766
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 4840411
• MDR Text Key: 20777184
• Report Number: 3005011024-2015-00003
• Device Sequence Number: 1
• Product Code: KDD
• 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,user facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 06/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-6900
• Device Lot Number: 37572926
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/05/2015
• Event Location: Hospital
• Date Manufacturer Received: 05/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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