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

Catalog Number 10144

Device Problems Chemical Spillage (2894); Device Handling Problem (3265)

Patient Problem Skin Irritation (2076)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Reference asp complaint # (b)(4).

Event Description

The customer reported a healthcare worker (hcw) came in contact with h2o2 from a leaking sterrad® 100nx cassette while trying to insert the new cassette into the sterrad®100nx sterilizer without wearing personal protective equipment (ppe).The hcw experienced a ¿prickle feeling¿ after moisture ran down his/her arm.There is no report that the skin turned white, but only one drop of h2o2 made contact with the arm.The hcw washed the affected area with running water, and then visited a doctor.It is unknown if any medical attention was given, however, it was reported the hcw has ¿recovered.¿ the hcw reported checking the chemical indicator located inside the packaging and there were no signs of color change or indication of h2o2 leakage.There are no serious injuries reported in this complaint.However, this skin reaction was due to contact with h2o2 from a leaking sterrad 100nx cassette; therefore, this event is being reported as a malfunction subsequent to a serious injury.

Manufacturer Narrative

The investigation included a review of the device batch record, lot trending, and system risk analysis (sra).The device batch record was reviewed and did not reveal any indication on a deviating quality profile for this batch.No events or deviations were reported.All in-process controls corresponded to the specification.Trending analysis by lot number was reviewed from (b)(6) 2017 to (b)(6) 2017 and no significant trend was observed.The sra shows the risk for exposure to toxic or corrosive material to be "low." the suspect cassette was returned to the supplier for further investigation which confirmed the reported event of the leaking cassette.Cell #1 was found to be partially empty and cell #2 was completely empty.There was no sign of an external mechanical impact which could have caused the defect.The issue could be attributed to a deviation where metal (brass) particles were detected in a few cellblock cells of some batches.The brass particles lead to a reaction of h2o2 and to a blowing of single cells due to the development of o2.The appearance of the defect indicates that it might have been caused by the issue described above.The foil wrapping was inspected for the leak indicator not turning red.While the cassette itself and the outside of the foil wrapping was completely soaked with h2o2, the absorbent laminate on the inside was completely dry with no traces of h2o2.This shows that no liquid reached the indicator stripe, and the indicator stripe could not turn red.It is extremely unlikely that the absorbent dried after being wet as all parts were packaged in plastic bags, and the outsides were completely soaked with h2o2.Overall, this indicates that the leakage did not occur while the cassette was inside the foil wrapping which was sent back together with the cassette.Thus, the indicator bar of the foil wrapping received as field sample could not turn red.The most likely cause of the of the h202 contact is due to use error and handling of the cassette without the use of personal protective equipment (ppe).The likely assignable cause of the indicator stripe not changing to the appropriate color could not be confirmed but likely could be due to the deviation described above.A customer letter will be sent advising to always wear ppe while handling cassettes.The issue will continue to be tracked and trended.

Manufacturer Narrative

Device available for evaluation? changed from no to yes.Device evaluated by manufacturer? changed from not returned to manufacturer to yes.The batch record review did not indicate a deviating quality profile for this batch.No events or deviations were reported that could relate to this issue.Functional testing performed.One open cassette of lot 17f085 was received.The cassette¿s foil package was soaked with liquid.The leak indicator stripe did not turn red/did not indicate a leak.Further evaluation found cell #1 was partially empty and cell #2 was completely empty.There was damage at the lower piercing zone of cell #1, and there was a damage at the upper piercing zone of cell #2.The cellblock was inspected microscopically by the lab: cell #1 of the sterrad cassette showed a rupture located at the lower tip of the cell.The edges of the rupture were found to be exposed to the exterior of the cell.No materials foreign to the cell plastic material were observed.Cell # 2 of sterrad cassette showed a rupture located at the top of the tip of the cell.The edges of the rupture were found to be exposed to the exterior of the cell.No materials foreign to the cell plastic material were observed.Thus, there is no sign of an external mechanical impact which could have caused the defect.

• Brand Name: STERRAD® 100NX CASSETTE
• Type of Device: STERRAD® EQUIPMENT
• Manufacturer (Section D): ADVANCED STERILIZATION PRODUCTS; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): ASP IRVINE MFG; 33 technology drive; irvine CA 92618
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 9497893837
• MDR Report Key: 7144208
• MDR Text Key: 95953076
• Report Number: 2084725-2017-00691
• Device Sequence Number: 1
• Product Code: MLR
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2018
• Device Catalogue Number: 10144
• Device Lot Number: 17F085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2017
• 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