MAUDE Adverse Event Report: ADVANCED STERILIZATION PRODUCTS STERRAD 100NX CASSETTE; STERRAD 100NX STERILIZER

Catalog Number 10144

Device Problem Chemical Problem (2893)

Patient Problem Skin Irritation (2076)

Event Date 08/07/2014

Event Type  malfunction  

Manufacturer Narrative

Manufacturer date: 04/09/2014.\ asp investigation summary: the investigation included a review of the batch record review, service history, trending of the product malfunction code, failure mode and effects analysis (fmea), and system hazard user misuse analysis (shuma).Method: service history, trending, fmea, and shuma reviewed.¿the batch record review was reviewed and no issues relating the failure mode were noted.The batch met manufacturer specifications at the time of release.¿the service history for the past six months ((b)(4) 2014) did not identify any significant trend.¿the trend for the product malfunction code of skin reaction was assessed from (b)(6) 2014.The risk is considered "acceptable after being reduced as low as possible." ¿ trending analysis by lot number was reviewed from (b)(4) 2014.There were no similar incidents within this time frame.¿the fmea revealed the risk priority number (rpn) scores are considered to be at an acceptable level.¿the shuma indicates the risk is "broadly acceptable." testing was not performed as there was no product returned.An asp field service engineer went onsite and found no evidence of the customer's claim of "popped cassette." no problem was found with the sterrad® unit as well.The severity of the issue was defined as "moderate." review of tracking and trending data did not reveal a trend that needed further investigation.

Event Description

A facility reported a healthcare worker (hcw) came in contact with hydrogen peroxide while loading a cassette into a sterrad® 100nx.The hcw was wearing unspecified personal protective equipment (ppe) and experienced "burning hot tingling, itching" on her arm, hand, wrist and finger for 45 minutes.The hcw flushed her hand with water for 15 minutes and washed it with soap.The hcw then visited the onsite doctor who administered first aid and did not prescribe any treatment.This event is being reported as a malfunction report subsequent to a serious injury event dated (b)(6) 2014.

Manufacturer Narrative

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• Brand Name: STERRAD 100NX CASSETTE
• Type of Device: STERRAD 100NX STERILIZER
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer Contact: ginny stamberger ; irvine, CA 92618 ; 9497893837
• MDR Report Key: 4045386
• MDR Text Key: 13024856
• Report Number: 2084725-2014-00285
• Device Sequence Number: 1
• Product Code: MLR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2015
• Device Catalogue Number: 10144
• Device Lot Number: 14D047
• Other Device ID Number: 10144
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 08/28/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 74 YR