MAUDE Adverse Event Report: DEROYAL INDUSTRIES DEROYAL HOT/COLD PACK, 4.5IN X 9.5IN, 20/CS; PACK, HOT OR COLD, DISPOSABLE

Catalog Number 9380-20

Device Problem Product Quality Problem (1506)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/18/2014

Event Type  malfunction  

Event Description

The ice packs are not only leaking but the holes these are developing are 1/4" or bigger.These ice packs are spilling out onto the patient, getting the dressing soaked, and even getting near or on the patient's wound.

Manufacturer Narrative

Investigation findings: no sample was returned.During a review of the information listed in this qfi, i found that the product was being purchased from a distributor.With that being said, i reviewed the routing of the product - first the raw materials are pulled at the fab facility and shipped to (b)(4).At (b)(4) the packs are counted out and 20 are packaged/labeled then shipped (b)(6).Once the order is placed the finished good is pulled/billed and shipped to, in this case cardinal.Cardinal gets an order and ships the product to the facility that is filing the complaint.The facility is then placing the product on shelves in a freezer, before it is placed on the patient.These items are bright blue in color any leaks should be quite easily seen during handling.We are unsure if the product was damaged prior to having been used.The vendor was informed about the issues and requested samples, however, we were unable to provide any.They are unwilling to take responsibility for the damaged packs as there were no issues found during deroyal handling/review.We will be getting future orders from our old vendor as the facility has been reopened.Correction: replacement sent.Root cause analysis: possible enduser issues.Corrective action and/or systemic correction action taken: no further action is required as no vendor defect/error could be found.

• Brand Name: DEROYAL HOT/COLD PACK, 4.5IN X 9.5IN, 20/CS
• Type of Device: PACK, HOT OR COLD, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES; 164 giles hollow rd; rose hill VA 24281
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653622333
• MDR Report Key: 4009150
• MDR Text Key: 4691982
• Report Number: 1123071-2014-00016
• Device Sequence Number: 1
• Product Code: IMD
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/11/2014

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: 9380-20
• Device Lot Number: MH73912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/18/2014
• Initial Date FDA Received: 07/14/2014
• 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
• Patient Outcome(s): Required Intervention