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 09/06/2017

Event Type  malfunction  

Manufacturer Narrative

Lot number 1601 from (b)(6).This lot number has undergone a previous passive field removal towards the end of last year.Aesculap initiated a change to the indicator ink through our contract manufacturer in an attempt to switch to a lead free ink base.Even though the new ink was fully tested by our manufacturer before release, we still received some complaints in relation to the color change and fading post-sterilization.It was considered to be very low risk, as these locks are intended to be used as a secondary indicator.The affected lot numbers were as follows: us906 indicator dot with lot numbers 1503, 1506, 1508, 1511, 1601, 1603, 1606, 15031, 15051, 15071, 16011, 563741-01, 563742-01, 563743-01, 563744-01, 563745-01, 563746-01.As you can see, the lot number reported was part of the affected product.Please advise the customer to check any lot numbers they may have in storage to make sure they do not have any of the above lot numbers.Also, please advise them to remove all locks from their workstations before replacing them with new locks.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 indicator dots are not turning dark.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 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: 9973416
• MDR Text Key: 206860962
• Report Number: 2916714-2020-00107
• 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: 1601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2017
• 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