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

Catalog Number 956-522

Device Problems Corroded (1131); Nonstandard Device (1420); Device Contaminated During Manufacture or Shipping (2969)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

A recall (fan 915-352 rev 2) was issued on november 9th, 2016 on the affected lot.No products from the affected lot have been sold in the usa.

Event Description

According to the complaint, the surface of the needle is covered by corrosion/rust.The customer stated that more than 10 pieces have corrosion in that box.The samplers were not taken into clinical use, as the user detected the needle coating.

Manufacturer Narrative

Additional samplers from the affected lot have been returned to radiometer as stated in this report.The samplers will be returned to radiometer headquarters for analysis.The root cause investigation of this event is ongoing.The status is given here: - it has been concluded, that the stainless steel used for the needle is the right grade/quality.- most likely root cause for the corrosion is contact with high concentrations of chloride.- supply chain investigation for deviations and potential contact with substances containing chloride showed no deviations in supply chain and no substances containing chloride were identified - investigation of extend of corrosion issue, geographical and across batches showed that corrosion has only been reported from (b)(6) , and no reference samples from affected lots shows signs of corrosion.In addition, no adjacent batches show sign of corrosion.- an attempt has been made to recreation of corrosion of needles at radiometer.Tests performed to recreate corrosion, no success yet.Tests will continue.- root cause investigation at supplier of needle is ongoing.

Manufacturer Narrative

(b)(4).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)(6).- only a few needles (<10) of each sampler lot have signs of corrosion.A lot size is typically 40.000-60.000 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.Literature 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)(6).- 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.

• Brand Name: SELF-FILLING PICO70 SAMPLERS
• Type of Device: PICO70
• Manufacturer (Section D): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, DK-27 00; DA DK-2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; aakandevej 21; broenshoej, DK-27 00; DA DK-2700
• Manufacturer Contact: kristina toft ; aakandevej 21; broenshoej, 2720 ; DA 2720 ; 538273349
• MDR Report Key: 6116132
• MDR Text Key: 60865362
• Report Number: 3002807968-2016-00037
• Device Sequence Number: 0
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K962158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/27/2017
• Device Catalogue Number: 956-522
• Device Lot Number: RW-55
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/27/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1