MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SELF-FILLING PICO70 SAMPLERS

Model Number	956-522
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2016
Type of Reportable Event	Malfunction
Event or Problem Description
According to the complaint, the needle is rusty.The complaint concerns the following amount of products: 956-522 lot ub52 7 samplers, 956-522 lot rv53 2 samplers, 956-522 lot rw-55 6 samplers.The samplers was not taken into clinical use, as the user detected the needle coating during a check of the storage.
Additional Manufacturer Narrative
On january 25th, 2017 radiometer issued a field action to recall the affected products from china.The investigation has shown the following: corrosion of needles has been identified on 4 lots of item number 956-522.- the 4 lots in interest have been distributed to 11 countries world-wide.Corrosion only identified on samplers sold in (b)(4).- only a few needles (<10) of each sampler lot have signs of corrosion.A lot size is typically (b)(4) samplers.Root cause investigation - 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.Litterature investigation and experts statements.- by testing of reference samples, it has been concluded that exposure to chloride occurs after samplers have been shipped to (b)(4).- 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.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.
Additional Manufacturer Narrative
Information has been added to which was missing in the initial report.

• Brand Name: SELF-FILLING PICO70 SAMPLERS
• Common Device Name: PICO70
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, DK-27 00; DA DK-2700
• MDR Report Key: 6192513
• Report Number: 3002807968-2016-00043
• Device Sequence Number: 13466043
• Product Code: JKA
• UDI-Device Identifier: 05700699565228
• UDI-Public: (01)05700699565228(17)171231(10)UB52;(01)05700699565228(17)170430(10)RV53;(01)05700699565228(17)170531(10)RW55
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 956-522
• Device Catalogue Number: 956-522
• Device Lot Number: RW-55, RV-53, UB-52
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 01/26/2017; 03/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1