MAUDE Adverse Event Report: CLINICAL INNOVATIONS EUROPE, LTD. ROM PLUS COMPLETE KIT; IMMUNOASSAY FOR DETENTION OF AMNIOTIC FLUID PROTEIN(S)

Model Number ROM-5025

Device Problem Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/29/2018

Event Type  malfunction  

Event Description

Rom plus complete kit, not enough liquid in the vial.Original kit discarded, new one obtained, no negative impact to patient.Original packaging available for return.

• Brand Name: ROM PLUS COMPLETE KIT
• Type of Device: IMMUNOASSAY FOR DETENTION OF AMNIOTIC FLUID PROTEIN(S)
• Manufacturer (Section D): CLINICAL INNOVATIONS EUROPE, LTD.; heathrow UB11 1FW; UK UB11 1FW
• MDR Report Key: 7925985
• MDR Text Key: 122630056
• Report Number: MW5080250
• Device Sequence Number: 1
• Product Code: NQM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: ROM-5025
• Device Lot Number: 180484
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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: 34 YR