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 08/01/2018

Event Type  malfunction  

Manufacturer Narrative

Crosstex (sps) recently received a complaint stating that us906 indicator dots were not transitioning to a darker color post sterilization.Suspect product was returned to crosstex for further testing during the investigation of the reported failure mode.The lot numbers provided, 580031-01 and 582691-01, are not recognized as issued by crosstex.Since the lot numbers are reassigned outside of crosstex, we are unable to perform a batch record review.Returned product was subjected to a standard steam sterilization cycle at 270 degrees for four (4) minutes.Two (2) surgical containers consisting of thirty (30) orange locks each were used in an attempt to replicate the results reported for this failure mode.Upon review, it has been determined that all dots tested for both respective lots have transitioned as intended.Since the results could not be replicated, the complaint cannot be confirmed.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, this complaint will be re-evaluated.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 color on the orange tags did not turn to a darker color.No patient injury.No delay in surgery.No additional intervention.

• 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: 10002971
• MDR Text Key: 194555813
• Report Number: 2916714-2020-00133
• 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
• Device Lot Number: 582691-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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