MAUDE Adverse Event Report: SPS MEDICAL (CROSSTEX) STEAM STER LOCKS ORANGE; STERILE TECHNOLOGY

Model Number US906

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

Us906: upon initial inspection no abnormalities could be noted with the dots.A 3m lead check test was utilized on a sample of the dots to confirm that these dots were manufactured with lead-based ink.Dots from lots 1508 - 1605 were manufactured with a different formulation, non-lead based, and had similar reports of color reversion.It was confirmed that these dots were manufactured with the correct lead-based formulation.It was also noted that while the color change of the dots had a variance from grey to black, a color transition had occurred from the signal color.Per internal procedures a batch record review was performed due to the absence of lot number reporting, and no abnormalities or non conformances were noted during this comprehensive review.Note: a retrospective review of potential serious injury complaints was performed.This mdr was identified as a reportable malfunction as a result and filed as part of the review activities.

Event Description

It was reported there was an issue with the orange locks.The reporter indicated that the locks are not changing colors properly.There may be issues with both color reversion of the dot and initial color change of the dot.No patient injury.No delay in surgery.

• Brand Name: STEAM STER LOCKS ORANGE
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): SPS MEDICAL (CROSSTEX); 6789 w. henrietta road; rush, ny
• Manufacturer (Section G): AESCULAP INC; 3773 corporate parkway; center valley, pa
• Manufacturer Contact: lindsay chromiak ; 3773 corporate parkway; center valley, pa ; 2581946507
• MDR Report Key: 9979292
• MDR Text Key: 195043761
• Report Number: 2916714-2020-00119
• Device Sequence Number: 1
• Product Code: KCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890759
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: US906
• Device Catalogue Number: US906
• Device Lot Number: 573949-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1