MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO; SAFEPICO ASPIRATOR

Model Number SAFEPICO 23GX16 MM

Device Problem Fluid/Blood Leak (1250)

Patient Problem Exposure to Body Fluids (1745)

Event Date 09/01/2014

Event Type  malfunction  

Event Description

According to the complaint the customer experienced a blood leak during sampling from where the needle is attached to the samplers.This was seen on 4 samplers from the same lot.The nurses were not wearing gloves and got in contact with pt blood.No reports of any injuries related to this event has been received.

Manufacturer Narrative

Unfortunately it was not possible to obtain any samplers back from the customer for investigation.The samplers in the retention stock, from the same lot, have been investigated, and based on this investigation there is no indication that the product has malfunctioned.However, since it was not possible to investigate the failing product, the root cause of this problem has not been identified.This event is therefore reported as a product malfunction, since this cannot be excluded.

• Brand Name: SAFEPICO
• Type of Device: SAFEPICO ASPIRATOR
• Manufacturer (Section D): RADIOMETER MEDICAL APS; bronshoj 2700 ; DA 2700
• Manufacturer Contact: akandevej 21; bronshoj 2100 ; 8273827
• MDR Report Key: 4281169
• MDR Text Key: 19974455
• Report Number: 3002807968-2014-00053
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K043143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/07/2014

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: 08/31/2016
• Device Model Number: SAFEPICO 23GX16 MM
• Device Catalogue Number: 956-615
• Device Lot Number: RB50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2014
• Initial Date FDA Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2014
• 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