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 11/14/2018

Event Type  malfunction  

Manufacturer Narrative

A complaint was received stating that lock tags with the us906 steam sterilization dots are reverting back to their signal color post sterilization.No lot number was available upon submitting the complaint to (b)(4) (sps).Suspect product was forwarded to aid in an investigation.Suspect product was tested in a standard, pre-vacuum steam sterilization cycle at 270 degrees fahrenheit for 4 minutes with a dry time of thirty (30) minutes.Upon completion of the sterilization cycle, locks were visually inspected and subjected to a lead test to confirm the ink formulation used during the manufacturing process.Results of the lead test show that this specific lot is lead free.Reports of color reversion were confirmed for lots 1508 - 1605 when it was noted that a new, lead-free formulation used for these lots resulted in high product sensitivity to light, heat, and other sterilants.As a result of these reports, the original lead-based formulation was reinstated for lot 1606 to present day, with lot 1606 being manufactured in (b)(4) 2016.No confirmed complaints from (b)(4) 2016 to present for color reversion are on file, indicating that this change to the leaded formulation was effective in addressing this issue.This issue has been logged and will be monitored for recurrence.Should you experience additional complaints in relation to this failure mode, or should a lot number become available, a re-assessment will be completed.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.The complained product was not returned and the batch # was not provided.Due to the time frame, it was reasonable to assume that the product fell within the scope.

Event Description

It was reported there was an issue with the orange locks.The reporter indicated that the indicator dots on lock tags turned back to original color.No serious injury or death.This incident did not cause or contribute to a delay in surgery.No additional intervention mentioned on form.

• 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: 10002961
• MDR Text Key: 192478991
• Report Number: 2916714-2020-00145
• 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: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2020
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2018
• 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