MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO70

Model Number	956-613
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, the user was preparing to perform an arterial blood sampling on the patient using safepico70 sampler (lot number: bv06).Upon opening the outer packaging, and inspecting the sampler, the user noticed the needle had corroded with foreign objects inside the needle hub.The user immediately replaced it with a new sampler and was not used for treatment.
Additional Manufacturer Narrative
Date of event is estimated.Radiometer have checked all of the available reference samples in visual inspection.All reference samples within specification.Corrosion on the needle has not been observed.However, the investigation is still ongoing and hence the root cause is not identified yet.On 2024-11-06, radiometer decided to recall the affected lot: (bv06).The lot was not distributed to the us, and hence the us is not affected.Due to the suspected root cause and the product was only distributed to china, the stock recovery is only affected in china.
Additional Manufacturer Narrative
Radiometer investigations of the returned defective product, showed that the product was likely exposed to a chlorine containing chemical agent.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 the root cause is unknown.

• Brand Name: SAFEPICO70
• Common Device Name: SAFEPICO70
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• Manufacturer Contact: pearlyn pah ; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 20629824
• Report Number: 3002807968-2024-00073
• Device Sequence Number: 8038891
• Product Code: JKA
• UDI-Device Identifier: 05700699566133
• UDI-Public: (01)05700699566133(17)260412(10)BV06
• 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
• Report Date (Section B): 01/03/2025

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 Expiration Date: 04/12/2026
• Device Model Number: 956-613
• Device Catalogue Number: 956-613
• Device Lot Number: BV06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 12/12/2024
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2024
• 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