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	06/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, on (b)(6) 2024, as the nurse was preparing to perform a blood gas analysis test on a patient, she checked the safepico (lot number: na01) and confirmed that it was airtight and within its expiration date.However, upon opening the package and rechecking the device, the nurse found that the needle of the safepico was rusty.The rusty needle was not used for treatment.
Additional Manufacturer Narrative
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.Production documentation of the affected lot was checked and found no deviations.11 defective samples delivered and checked under visual inspection.On samples there is foreign matter on samplers needles.After opening the bag with samples, a chemical odor reminiscent of chlorine immediately emerged.However, the investigation is still ongoing and hence the root cause is not identified yet.On 2024-07-15 radiometer decided to recall the affected lot (na01).The lot was not distributed to the us, and hence the us is not affected.Due to the suspected root cause, the stock recovery is only affected in china.
Additional Manufacturer Narrative
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.Production documentation of the affected lot was checked, and found no deviations.11 defective samples delivered and checked under visual inspection.On samples there is foreign matter on samplers needles.After opening the bag with samples, a chemical odor reminiscent of chlorine immediately emerged.Chlorine is not used at any stage of radiometer production process.Hence, the root cause could be due to exposure of chemical agent containing chlorine after production process.

• 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: 19622599
• Report Number: 3002807968-2024-00036
• Device Sequence Number: 6359746
• Product Code: JKA
• UDI-Device Identifier: 05700699566133
• UDI-Public: (01)05700699566133(17)240810(10)NA01
• 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): 08/22/2024

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: 08/10/2024
• Device Model Number: 956-613
• Device Catalogue Number: 956-613
• Device Lot Number: NA01
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 08/01/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/06/2024; 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/10/2022
• 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