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

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.

• Brand Name: CROSSTEX SPS SPORVIEW CULTURE SET
• Type of Device: CROSSTEX SPS SPORVIEW CULTURE SET
• Manufacturer (Section D): CROSSTEX SPS MEDICAL
• MDR Report Key: 7742284
• MDR Text Key: 116066367
• Report Number: MW5078765
• Device Sequence Number: 1
• Product Code: MRB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2019
• Device Model Number: SPS SPORVIEW CULTURE SET
• Device Catalogue Number: CS-020
• Device Lot Number: 580
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1