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 08/15/2017

Event Type  malfunction  

Manufacturer Narrative

Suspect product is from lot 1607.No samples or cycle parameter information is available for additional analysis.At present, no instances of color reversion have been noted for lot 1607, with this incident representing the first reporting.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.As a precaution, processed retains from lot 1607 were retrieved and examined for reversion, with no instances of reversion noted.When steam indicator dots are converted onto their orange locks, lot traceability can be very difficult to maintain, and the possibility of having mixed lots at the point of use is very likely.With lot 1607 having a date of manufacture very close to the unleaded formulation dots, it is possible that both leaded and unleaded formulation dots have become mixed at the point of use.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 indicator dots are turning back to the original color.Discovered in sterile processing.No patient harm or surgical delay reported.

• Brand Name: STEAM STER LOCKS ORANGE
• Type of Device: STERILE TECHNOLOGY
• Manufacturer (Section D): SPS MEDICAL (CROSSTEX); 6789 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: 9973418
• MDR Text Key: 194550966
• Report Number: 2916714-2020-00105
• 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: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• 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: 1607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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