MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC RAPID ASSAY PIFA HEPARIN PLATELET FACT4; PLATELET FACTOR 4 RADIOIMMUNOASSAY

Model Number 4036025A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Date 09/17/2018

Event Type  Injury  

Manufacturer Narrative

Investigation into this reported incident is currently under investigation.A follow up report will be submitted by cardinal health.

Event Description

Plaintiff alleges that the ifu for the pifa test has specific storage conditions.Plaintiff further alleges that the cardinal health defendants were negligent in the transportation, shipping, storage and distribution of the pifa test including in failing to ensure the pifa tests were transported, shipped, stored, and distributed in accordance with the ifu; delivering pifa tests that had not been transported, shipped, stored, and distributed in accordance with the requirements in the ifu; failing to take reasonable measures to prevent affected pifa tests from being sold; failing to reasonably ensure that the pifa tests remained refrigerated throughout the distribution process; and failing to establish and maintain quality control to prevent defective shipping and distribution of the pifa tests.

Manufacturer Narrative

Product code 4036025a, rapid assay pifa heparin platelet fact4, manufactured by akers biosciences inc., manufacturer number 4036025, shipped to our cardinal health facility between 1/1/18 thru 8/30/2020.Upon receipt, products were removed from delivery trailers within the required timeframe per cardinal health policy and placed into refrigerated storage per labeled product storage conditions.Cardinal health shipped two orders to the hospital during this time.The products were packed in boxes with foam and the product is wrapped in plastic with ice on top and bottom per cardinal health policy and as directed by the manufacturer.As part of the shipping process, cardinal health stamps the paperwork with the time and date of packing and there is also a location for the customer to sign and note time of receipt.This stamp documents the amount of time the product is out of refrigerator and on ice.Cardinal health received no notification of this product being received past required time frame.There is no evidence of any temperature issue during this time with the product in question.No customer complaints have been received for a temperature issue on item 4036025a.There were no findings of any failures, therefore, the root cause could not be determined for this case.

• Brand Name: RAPID ASSAY PIFA HEPARIN PLATELET FACT4
• Type of Device: PLATELET FACTOR 4 RADIOIMMUNOASSAY
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 10691976
• MDR Text Key: 211844495
• Report Number: 1423537-2020-00545
• Device Sequence Number: 1
• Product Code: LCO
• UDI-Device Identifier: 00708872615123
• UDI-Public: 00708872615123
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4036025A
• Device Catalogue Number: 4036025A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other