MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO70

Model Number 956-613

Device Problems Corroded (1131); Material Integrity Problem (2978)

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

Event Date 09/26/2022

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 301737448
• Report Number: 3002807968-2022-00034
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 05700699566133
• UDI-Public: (01)05700699566133(17)240420(10)MS07
• 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,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/14/2022
• Supplement Dates Manufacturer Received: 10/13/2022; 10/02/2022
• Supplement Dates FDA Received: 11/10/2022; 12/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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