MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. 0.8% RESOLVE C 22X3ML; REAGENT RED BLOOD CELLS

Catalog Number	6902319
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6) - investigation details: as part of the investigation, verification of infectious disease testing for 0.8% resolve panel c lot vrc321, cells 4, 5, 6 and 7 was performed.The units used in the production of cells 4, 5, 6, and 7 of 0.8% resolve panel c lot vrc321, have been tested for hbsag, sts, antibodies to hcv, htlv i/ii, hbc, hiv 1 and 2, west nile virus, and nat test for hiv, hbv, and hcv and found acceptable.Each donor is tested for antibodies to t.Cruzi once and found acceptable.((b)(6)) additionally, a review of the worldwide complaint databases for splash complaints from 08apr2023 through 24apr2024.A total of (b)(4) complaints were identified for the year.One is related to the investigation underway.The second complaint is unrelated to reagent red cells and is involving a non-ortho manufactured product.No trend for splash complaints was observed.((b)(6)) finally, a medical consultation was performed with (b)(6), md, mph via email regarding the reported event.The following response was provided: "since donors and donation blood for ortho reagents were tested negative in accordance with current fda required tests, the chance for this technician to be transmitted with the common blood borne pathogens is low.However, no test can guarantee 100% detection and there might be unknown pathogens not tested.So, for precaution, this case is classified as a serious injury." there was no evidence of any systematic failure of the ortho clinical diagnostics reagents or analyzer to perform as intended.No further complaints of this type have been received from the customer site since the time of the reported event.
Event or Problem Description
Cms 2611389, windchill (b)(6) complaint description: on (b)(6) 2024, the customer contacted ortho's global technical solutions center (gtsc) reporting a direct splash event at their site involving 0.8% resolve panel c, lot vrc321 potentially cells 4, 5, 6 and 7, splashing directly into the eyes of the operator as the vials were being loaded onto the analyzer.The operator was not wearing eye protection at the time of the event.Complainant: (b)(6) (medical technologist) (b)(6), customer#(b)(6), (b)(6) hospital (b)(6), event date: 08apr2024 at approximately 1pm, reported same day approximately 6p est.Product: 0.8% resolve panel c lot vrc321, expiry 16apr2024, manufactured 30jan2024.Customer states the operator flushed their eyes for a minimum of fifteen minutes according to the customer's standard operating procedures (sop).Operator was in contact with their safety officer and was administered immediate prophylaxis medication.Blood was drawn and will be tested for infectious diseases.Operator will have repeat testing per their site policy in three weeks and until six months has passed.Customer states operator's vision does not appear to be impaired, and operator is feeling well.Operator is stable and no physical injury is observed.Customer stated they will be reporting the event to the fda.No others were affected by this event.Gtsc referred the customer to sds sheets and product ifu.Caution is provided in the ifu: "all blood products should be treated as potentially infectious.Source material from which this product was derived was found negative when tested in accordance with current fda required tests.No known test methods can offer assurance that products derived from human blood will not transmit infectious agents.".

• Brand Name: 0.8% RESOLVE C 22X3ML
• Common Device Name: REAGENT RED BLOOD CELLS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 1001 us highway 202; raritan NJ 08869
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 19228227
• Report Number: 2250051-2024-00013
• Device Sequence Number: 6834192
• Product Code: QHT
• UDI-Device Identifier: 10758750007691
• UDI-Public: 10758750007691
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2024

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: 6902319
• Device Lot Number: VRC321
• 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: 04/08/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown