CROSSTEX SPS SPORVIEW CULTURE SET CS-020

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-08-01 for CROSSTEX SPS SPORVIEW CULTURE SET CS-020 manufactured by Crosstex Sps Medical.

Event Text Entries

[116066367] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5078765
• MDR Report Key: 7742284
• Date Received: 2018-08-01
• Date of Report: 2018-07-27
• Date of Event: 2018-06-27
• Date Added to Maude: 2018-08-02
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: CROSSTEX SPS SPORVIEW CULTURE SET
• Generic Name: CROSSTEX SPS SPORVIEW CULTURE SET
• Product Code: MRB
• Date Received: 2018-08-01
• Model Number: SPS SPORVIEW CULTURE SET
• Catalog Number: CS-020
• Lot Number: 580
• Device Expiration Date: 2019-04-30
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CROSSTEX SPS MEDICAL

Patients

Patient Number	Treatment	Outcome	Date
1	0		2018-08-01