MAUDE Adverse Event Report: LP ITALIANA SEDIPLAST; ERYTHROCYTE SEDIMENTATION RATE MANUAL TEST; PRODUCT CODE JPH

Catalog Number S-1000

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

Patient Problem Not Applicable (3189)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

When the problem was reported to polymedco, polymedco performed testing on retain material for the lot u0738b, using a glycerol solution to mimic consistency of whole blood.None of the tubes that were tested were found defective and all performed acceptably.The actual kit that was used by the laboratory technician was finally returned to polymedco on 08/08/2016 and tested.The 59 tests remaining in the kit of 100 tests were tested with erythrocyte controls and with the glycerol solution.One of the 59 tubes demonstrated leakage of the contents from the top of the tube.Records of incoming quality control testing for the lot were reviewed.The lot passed incoming qc testing, which involves testing of a sample from the lot with the glycerol solution.No physical defects were identified in the inspection sample.Resubmitting mdr 1/13/2017 due to upload errors.Mdr originally uploaded 11/16/2016.

Event Description

When using sediplast s-1000 lot u0738b on patient blood, the sample escaped from the top of tube and exposed the laboratory technician to the patient blood, the customer reported that the technician was tested for (b)(6) with negative results.From the report submitted by the user: "while setting up a esr i was splashed in the eye with a patients blood.This was due to a failure of the esr tube top as it allowed the blood to escape the top of the measuring column.The lot number of the device is u0738b.The manufacturer is polymed".

• Brand Name: SEDIPLAST
• Type of Device: ERYTHROCYTE SEDIMENTATION RATE MANUAL TEST; PRODUCT CODE JPH
• Manufacturer (Section D): LP ITALIANA; via carlo reale, 15/4; milano, lombardy 19643 204; IT 19643204
• Manufacturer Contact: helen landicho ; 510 furnace dock road; cortlandt manor, NY 10567 ; 4252600201
• MDR Report Key: 6251740
• MDR Text Key: 65233442
• Report Number: 9614769-2017-00001
• Device Sequence Number: 1
• Product Code: JPH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 02/28/2017
• Device Catalogue Number: S-1000
• Device Lot Number: U0738B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/12/2016
• Device Age: 13 MO
• Event Location: Other
• Date Report to Manufacturer: 08/09/2016
• Date Manufacturer Received: 07/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other