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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CROSSTEX SPS MEDICAL CROSSTEX SPS SPORVIEW CULTURE SET

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CROSSTEX SPS MEDICAL CROSSTEX SPS SPORVIEW CULTURE SET Back to Search Results
Model Number SPS SPORVIEW CULTURE SET
Device Problems Contamination (1120); Precipitate in Device or Device Ingredient (1478)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/27/2018
Event Type  Malfunction  
Event Description

Specifics are: crosstex sps sporview culture set. Cat no. Cs-020. Lot 580. Vials identified in 2 boxes with same batch number. Number of vials that appear contaminated: 5. ¿expiration april 30, 2019. When we received the new box from our logistics, many of the spore tubes were yellow or light purple with precipitate, instead of the nice clear purple. The caps on the vials appeared to be secure. The vials that appear to be contaminated appear to have less liquid volume in the vials. There also appears to be a small quarter size water spot on the boxes (top back). The concern is that this may result in a false positive, especially if clinics report receive a contaminated set but the color hasn't changed or precipitate detected. These vials were promptly removed from our instrument processing center. A phone call was made to crosstex at 1800-722-1529 to report the incident. They recommended to email qc@spsmedical. Com on june 27, 2018, but the email was rejected by the server. Another email was sent to info@spsmedical. Com on july 9, 2018 and addressed to spsmedical qa, but no response was received.

 
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Brand NameCROSSTEX SPS SPORVIEW CULTURE SET
Type of DeviceCROSSTEX SPS SPORVIEW CULTURE SET
Manufacturer (Section D)
CROSSTEX SPS MEDICAL
MDR Report Key7742284
MDR Text Key116066367
Report NumberMW5078765
Device Sequence Number1
Product Code MRB
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 07/27/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/01/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date04/30/2019
Device MODEL NumberSPS SPORVIEW CULTURE SET
Device Catalogue NumberCS-020
Device LOT Number580
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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