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

Catalog Number	ROM-QC
Health Effect - Clinical Codes	Tissue Damage (2104); Injury (2348)
Date of Event	04/08/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time we are waiting for the sample to be returned for evaluation.
Event or Problem Description
Customer called and reported getting "pricked" by glass in negative qc vial.It happened a second time when using the positive vial (same product pack-both positive and negative) lot number tba.The hospital employee is going to follow hospital protocol and get tested.Information given on ifu regarding contents of positive 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.
Additional Manufacturer Narrative
Device history lot revew: 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 (b)(6) 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.

• Brand Name: ROM-QCS
• Common Device Name: ROM PLUS® QUALITY CONTROL KIT FETAL MEMBRANE RUPTURE TEST
• Manufacturer (Section D): CLINICAL INNOVATIONS; 747 w 4170 s; murray UT 84123
• MDR Report Key: 8567067
• Report Number: 1722684-2019-00004
• Device Sequence Number: 1809789
• Product Code: JJX
• UDI-Device Identifier: 00814247020451
• UDI-Public: 00814247020451
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K110605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ROM-QC
• Device Lot Number: 180252
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Initial Date Received by Manufacturer: 04/29/2019
• Supplement Date Received by Manufacturer: 06/07/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other