MAUDE Adverse Event Report: RADIOMETER MEDICAL APS PICO70

Model Number PICO70

Device Problems Nonstandard Device (1420); Problem with Sterilization (1596); Device Disinfection Or Sterilization Issue (2909)

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

Event Type  malfunction  

Event Description

According to the customer 40-60% of the pico70 blood samplers received from lot lm-052 were within a brownish coating on the needles.The composition of the deposit has not yet been identified but it is assumed that the needles are not sterile.The packaging of the samplers is intact and has not been opened.All affected pico70 samplers were from the same lot.

Manufacturer Narrative

The reference stock of the affected lot has been inspected and no problems were found.No other reports have been received regarding this issue.One of the affected samplers was received for inspection and the deposit was sent to a lab in order to identify the composition.A recall will be conducted.No products from the affected lot has been sold in the usa.

• Brand Name: PICO70
• Type of Device: PICO70
• Manufacturer (Section D): RADIOMETER MEDICAL APS; bronshoj 2700 ; DA 2700
• Manufacturer Contact: akandevej 21; bronshoj 2100 ; 8273827
• MDR Report Key: 4239858
• MDR Text Key: 20976131
• Report Number: 3002807968-2014-00048
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K962158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 09/28/2014

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 Expiration Date: 01/31/2016
• Device Model Number: PICO70
• Device Catalogue Number: 956-529
• Device Lot Number: LM-52
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2014
• Initial Date FDA Received: 10/31/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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