MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO70

Model Number	956-613
Medical Device Problem Codes	Corroded (1131); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint the customer discovered a rusty needle on a safepico sampler.The customer returned the sampler box (100 pieces) back to radiometer on (b)(6) 2022.It was confirmed that the rusty needle was discarded and not used on a patient.
Additional 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.

• Brand Name: SAFEPICO70
• Common Device Name: SAFEPICO70
• Manufacturer (Section D): RADIOMETER MEDICAL APS; å]kandevej 21; brønshø]j, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; åkandevej 21; jbrønshøj, 2700 ; DA 2700
• Manufacturer Contact: cecilie jensen ; åkandevej 21; brønshøj, 2700 ; DA 2700
• MDR Report Key: 15605183
• Report Number: 3002807968-2022-00034
• Device Sequence Number: 11316568
• Product Code: JKA
• UDI-Device Identifier: 05700699566133
• UDI-Public: (01)05700699566133(17)240420(10)MS07
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K043143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/01/2022

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
• Operator of Device: Health Professional
• Device Model Number: 956-613
• Device Catalogue Number: 956-613
• Device Lot Number: MS07
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2022
• Supplement Date Received by Manufacturer: 10/13/2022; 10/02/2022
• Initial Report FDA Received Date: 10/14/2022
• Supplement Report FDA Received Date: 11/10/2022; 12/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown