MAUDE Adverse Event Report: POLYMEDCO, INC. SEDIPLAST WESTERGREN ESR SYSTEM; TEST, ERYTHROCYTE SEDIMENTATION RATE

Catalog Number S100

Device Problem Explosion (4006)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/07/2020

Event Type  malfunction  

Event Description

Top of esr cap (pipette) blew off when inserting into vial.When inserting pipette into vial, the top of the pipette (cap) blew off and blood shot out of the top of the pipette.With the pressure that is needed to push the pipette into the vial, blood was shot all the way to the ceiling.

• Brand Name: SEDIPLAST WESTERGREN ESR SYSTEM
• Type of Device: TEST, ERYTHROCYTE SEDIMENTATION RATE
• Manufacturer (Section D): POLYMEDCO, INC. ; cortlandt manor NY
• MDR Report Key: 10683571
• MDR Text Key: 211478709
• Report Number: MW5097227
• Device Sequence Number: 1
• Product Code: JPH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: S100
• Device Lot Number: Y1319A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 59