3002807968-2018-00004
Report
- Report Number
- 3002807968-2018-00004
- Event Type
- Malfunction
- Date Received
- January 10, 2018
- Date of Event
- January 12, 2017
- Report Date
- October 3, 2018
- PMA / PMN Number
- K962158
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
IT HAS DISCOVERED THAT DATE OF EVENT AND DATE OF THIS REPORT WERE INCORRECTLY STATED. THUS, DATE OF EVENT SHOULD HAVE BEEN (B)(6) 2017) AND DATE OF REPORT JANUARY 10TH 2018 (10/01/2018). FOR YOUR INFORMATION, DATE RECEIVED BY MANUFACTURER REMAINS UNCHANGED.
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.
THE CUSTOMER COMPLAINED THAT THE NEEDLES OF PICO70 SAMPLERS SHOWED RUST WHILE STILL IN SEALED PACKAGING. NONE OF THE PICO70 SAMPLERS WITH RUST ON HAS BEEN USED ON PATIENTS.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |