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

Catalog Number 10144

Device Problems Chemical Problem (2893); Device Handling Problem (3265)

Patient Problems Skin Irritation (2076); Burning Sensation (2146)

Event Date 10/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

A customer reported a healthcare worker (hcw) received a skin reaction while removing the packaging from a sterrad® 100nx cassette and inserting it into the sterrad® 100nx sterilizer.There was no discoloration of the indicator strip to indicate any leak prior to use.The hcw was not wearing personal protective equipment at the time of the event and the hcw felt a prickle and the affected area turned white.The hcw washed the affected area with running water and the skin sensation disappeared after several minutes.The hcw reported they visited a doctor as a precaution but no diagnosis was given.There is no serious injury reported and the skin reaction resolved after a few minutes.Furthermore, there is no report that medical or surgical intervention was required to preclude a permanent impairment of a body function or permanent damage to a body structure.However, this skin reaction was due to contact with h2o2 from a sterrad® 100nx cassette and the leak indicator strip did not turn color; therefore, this event is being reported as a malfunction subsequent to a serious injury.

Manufacturer Narrative

The batch record review did not reveal any indication on a deviating quality profile for this batch.No quality issues were reported.All in-process controls corresponded to the specification.(b)(4).

Manufacturer Narrative

Asp investigation summary: the investigation included a review of the device batch record, trending analysis by lot number, system risk analysis (sra) and supplier product evaluation.Trending analysis by lot number for the issue of cassette leak-human contact and indicator strip is white was reviewed within the past six months and trending was not exceeded.The sra indicates the risk associated with exposure to toxic or corrosive material is "low." one cassette was returned for analysis.The foil wrapping and indicator were not included in the sample return.The cassette was removed from outer wrapping and liquid was visible through the protecting plastic bag.The cassette was completely soaked in h2o2.The label of the cassette was no longer legible due to liquid exposure.The batch name could not be confirmed, the identification on the cellblock (cellblock batch name 18e073) corresponds to the batch name of 100nx given in the complaint.No further investigation is performed on this cassette for safety reasons.As no further investigation is possible, the kind of damage cannot be investigated, neither can be evaluated whether this damage could have been caused by production.The obvious leak of the cassette can be confirmed.The assignable cause of the skin reaction while handling a leaking cassette can be attributed to user error as the healthcare worker was not wearing personal protective equipment (ppe) while handling a cassette.The assignable cause of the indicator on the cassette not changing color could not be confirmed since the returned product did not include the indicator and therefore, could not be evaluated.The customer was advised always wear ppe when handling cassettes.The issue will continue to be tracked and trended.Asp complaint ref #: (b)(4).

• Brand Name: STERRAD® 100NX CASSETTE
• Type of Device: STERRAD® 100NX STERILIZER
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• MDR Report Key: 8051590
• MDR Text Key: 127351139
• Report Number: 2084725-2018-00755
• Device Sequence Number: 1
• Product Code: MLR
• UDI-Device Identifier: 10705037014903
• UDI-Public: 10705037014903
• Combination Product (y/n): N
• PMA/PMN Number: K071345
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/19/2018

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: 06/27/2019
• Device Catalogue Number: 10144
• Device Lot Number: 18F069
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2018
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/08/2018
• Supplement Dates Manufacturer Received: 11/11/2018; 01/15/2019
• Supplement Dates FDA Received: 12/05/2018; 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STERRAD 100NX STERILIZER; STERRAD 100NX STERILIZER, SERIAL #: (B)(4)