MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Model Number 956-613

Device Problem Corroded (1131)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2022

Event Type  malfunction  

Manufacturer Narrative

The defective samplers were discarded, thus cannot be evaluated.Date of event is estimated based on awareness date.

Event Description

According to the complaint a nurse was preparing to collect arterial blood for the patient, but when she opened the outer package, she found that the blood gas needle was rusted.The sampler was discarded and not used on patients.

Manufacturer Narrative

Radiometer medical aps has concluded their investigation.Root cause of the needle corrosion has been identified as exposure of syringes to chlorine.By testing of reference samples, it has been concluded that exposure to chloride occurs after samplers have been shipped to china.- investigation of each step of the supply chain has been performed.- use of chloride containing gases has not been identified anywhere in the supply chain and would not be present during normal handling/storage/shipping.Hence, samplers from the same lot outside of china will not be affected.In h3 - device was discarded, but investigation tested device from same lot/batch.

• Brand Name: SAFEPICO
• Type of Device: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer Contact: cecilie jensen ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 16032706
• MDR Text Key: 306101642
• Report Number: 3002807968-2022-00045
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K043143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 956-613
• Device Catalogue Number: 956-613
• Device Lot Number: ME06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• 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