MAUDE Adverse Event Report: RADIOMETER MEDICAL APS PICO70

Model Number	956-533
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
The customer complained that there is needle corrosion on 11 pico70 blood samplers from the same box.
Additional Manufacturer Narrative
On (b)(6) 2020 radiometer decided to recall the affected lot (hu50) from china.Root cause investigation has confirmed that the root cause is the same as for previous similar incidents reported from china.The root cause of corrosion is exposure to high concentrations of chloride containing gas/liquid in a high temperature & high humidity environment.Analysis and investigations have been made to support this root cause: - chloride salts identified on syringes.- feo + fecl3 identified on corroded needles.- significant smell of chloride of samplers with corroded needles.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.Conclusion is that no systematic pattern of needle corrosion can be found.The corrosion is limited to a few needles of each lot, and will not be present during intended handling, storage and shipping.There have been no reports of patient harm.There have been no reports of corroded needles from any other country than china.

• Brand Name: PICO70
• Common Device Name: PICO70
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, 2700 ; DA 2700
• MDR Report Key: 10695401
• Report Number: 3002807968-2020-00044
• Device Sequence Number: 3708804
• Product Code: JKA
• UDI-Device Identifier: 05700699565334
• UDI-Public: (01)05700699565334(17)210808(10)HU50
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 11/13/2020

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: 08/08/2021
• Device Model Number: 956-533
• Device Catalogue Number: 956-533
• Device Lot Number: 956-533HU50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1