MAUDE Adverse Event Report: CLINICAL INNOVATIONS, LLC ROM PLUS QC; RUPTURE OF MEMBRANE TEST

Model Number	ROM-QC
Medical Device Problem Code	Missing Information (4053)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
In the cusotmers words: "hi, my name is (b)(6).My phone number is (b)(6).I was going to get information on one of your qc vials for your rom plus, the positive qc.One of the glass shards from the product actually broke through the vial and entered my finger.And i'm just trying to figure out what exactly was in the solution if you can give me a call back because i know you should get the chance i'd appreciate it.Thank you so much.Bye." 1st and 2nd attempt to call back with no response ((b)(6) 2023) phone conversation on (b)(6) 2023; customer states they did not use the included safety sleeve for the positive control vial.
Additional Manufacturer Narrative
The complaint is confirmed.No product evaluation could be performed, however, the complaint is considered confirmed because the customer described the incident over the phone.Investigation description a dhr review could not be performed because the lot number is unknown.The number of mfg caused devices field and dhr review section will remain blank.Risk assessment rom fmeas do not address this failure mode.Updates to relevant fmea documents will be made to address this type of failure and its associated risk.Root cause analysis inadequate ifu - the ifu does not mention the use of the vial safety sleeve.

• Brand Name: ROM PLUS QC
• Common Device Name: RUPTURE OF MEMBRANE TEST
• Manufacturer (Section D): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer (Section G): CLINICAL INNOVATIONS, LLC; 747 w 4170 s; murray UT 84123
• Manufacturer Contact: zulmar molina ; 747 w 4170 s; murray, UT 84123
• MDR Report Key: 18113385
• Report Number: 1722684-2023-00008
• Device Sequence Number: 6875540
• Product Code: JJX
• UDI-Device Identifier: 00814247020451
• UDI-Public: 00814247020451
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K110605
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/10/2023

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 Model Number: ROM-QC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 11/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown