MAUDE Adverse Event Report: NUCLETRON B. V. / ELEKTA INC. PROGUIDE SHARP NEEDLE 5FX 240MM; SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED

Model Number 189640-00

Device Problem Component or Accessory Incompatibility (2897)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/22/2019

Event Type  malfunction  

Event Description

A supply tech noticed that the indicator strips on two single use device sku's had not changed to the color indicated on package.The supplies are from nucletron and are as follows: proguide sharp needle 5fx 240mm ref 189640-00, all lot numbers in our facility, and smit sleeve, 60mm ref 189761-00, all lot numbers in our facility.Some smit sleeve packages show the indicator should be blue and some show it should be pink.The indicator that should be blue is orange, and the indicator that should be pink is blue and grey striped.The proguide needle indicator shows it should be pink and it is pink and blue striped.I reached out to the product mfr (nucletron/elekta) and they responded that the items were sterile and to ignore the marker as it was not designed for eto, and the products are sterilized using eto.I wanted to be sure the packaging was compatible with eto and also that the items really were sterile since the sterilization indicator on the package had not turned.After many calls and emails over the course of a few days to the package mfr (steriking) and to the mfr of the product, the following was determined: the packaging (steriking ltr41) is validated for eto sterilization, but the indicator strip on the package is not.The indicator strip is validated for use with vaporized hydrogen peroxide.Nucletron/elekta guarantees the items are sterile.My concern is to ask that healthcare professionals disregard sterilizer indicators that have not turned appropriately.This is not good practice and can lead to mistakenly ignoring an indicator on a package that should not have been ignored.Operating room techs are trained to check indicators and reject items if packaging indicators have not turned.

• Brand Name: PROGUIDE SHARP NEEDLE 5FX 240MM
• Type of Device: SYSTEM, APPLICATOR, RADIONUCLIDE, REMOTE-CONTROLLED
• Manufacturer (Section D): NUCLETRON B. V. / ELEKTA INC.
• MDR Report Key: 8600007
• MDR Text Key: 144946610
• Report Number: MW5086530
• Device Sequence Number: 1
• Product Code: JAQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/06/2023
• Device Model Number: 189640-00
• Device Lot Number: 60569755
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1