MAUDE Adverse Event Report: CLINICAL INNOVATIONS ROM-QCS; ROM PLUS® QUALITY CONTROL KIT FETAL MEMBRANE RUPTURE TEST

Catalog Number ROM-QC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tissue Damage (2104); Injury (2348)

Event Date 04/08/2019

Event Type  Injury  

Manufacturer Narrative

Device history lot review: there is nothing relative to the complaint.The lot met all specifications outlined for release.Sample analysis: the user returned the vial.It was determined on 6/7/2019 that this lot caused or contributed to the incident.A visual inspection indicated the vial was broken.The user broke the vial without use of the plastic sleeve.The complaint is confirmed.There is not further information from the end user if any further ill effect had occurred from this incident.This complaint has now been closed.Should any additional information be received, a supplemental will be filed.

Event Description

Customer called and reported getting "pricked" by glass in (b)(6) qc vial.It happened a second time when using the (b)(6) vial ( same product pack-both (b)(6)) lot number tba.The hospital employee is going to follow hospital protocol and get tested.Information given on ifu regarding contents of (b)(6) vial.The product is available and will be returned for evaluation.The ifu states the following: caution: this product contains human sourced and/or potentially infectious components.Components sourced from human blood have been tested and found to be nonreactive for hbsag, anti-hiv 1/2, and anti-hcv.No known test method can offer complete assurance that products derived from human sources or inactivated microorganisms will not transmit infection.Therefore, it is recommended that all human sourced materials be considered potentially infectious and handled with appropriate biosafety practices.

• Brand Name: ROM-QCS
• Type of Device: ROM PLUS® QUALITY CONTROL KIT FETAL MEMBRANE RUPTURE TEST
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: laura smith ; 747 w 4170 s; murray, UT 84123 ; 8012667373
• MDR Report Key: 8681135
• MDR Text Key: 147447832
• Report Number: 1722684-2019-00013
• Device Sequence Number: 1
• Product Code: JJX
• UDI-Device Identifier: 00814247020451
• UDI-Public: 00814247020451
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110605
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ROM-QC
• Device Lot Number: 180559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/07/2019
• Was Device Evaluated by Manufacturer?: No
• 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