3002807968-2018-00059
Report
- Report Number
- 3002807968-2018-00059
- Event Type
- Malfunction
- Date Received
- October 11, 2018
- Date of Event
- September 14, 2018
- Report Date
- November 7, 2018
- PMA / PMN Number
- K962158
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
ON MONDAY OCTOBER 8TH, 2018 RADIOMETER DECIDED TO RECALL THE AFFECTED LOTS (YM52 AND BC52). THE PRODUCTS HAVE ONLY BEEN DISTRIBUTED IN (B)(4) AND THE PROBLEM HAS ONLY BEEN REPORTED FROM (B)(4) , WHY (B)(4) IS NOT AFFECTED.
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. LITTERATUR 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.
ACCORDING TO THE COMPLAINT, IT LOOKS LIKE RUST ATTACHED ON THE SURFACE OF NEEDLES.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |