MAUDE Adverse Event Report: STERIS BIOLOGICAL OPERATIONS VERIFY V24 SCBI; BIOLOGICAL INDICATOR

Lot Number 161217E

Device Problems Break (1069); Device Damaged Prior to Use (2284)

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

Event Date 09/14/2016

Event Type  No Answer Provided  

Manufacturer Narrative

No report of injury.No procedure delays or cancellations were reported.The user facility stated that the box in which the scbis were shipped in did not evidence any damage.Each individual vial is inspected during manufacturing and again when they are placed in foam trays for final packing.To protect these vials from damage, each single vial is placed within its own cavity within a foam insert.An additional piece of foam is then placed on top.The dhr for the lot number subject of the reported event was reviewed and no abnormalities were found and all release criteria was met for the product.Retain testing was performed on the lot number subject of the reported event and no issues were noted; no cracked ampules in the vials were observed.The verify v24 self-contained biological indicator is composed of a delicate onion skin glass ampule of media inside a plastic vial.Damage to these ampules is most likely to occur during transit or during storage if any rough handling or excessive shaking of the outer package occurs, which causes the glass media ampule to come into contact with the walls of the vial.Evidence of this shaking may not be visible on either the shipping box or the product package and would be visible upon opening the package.

Event Description

The user facility reported via medwatch #(b)(4) that upon receipt of their verify v24 scbis, vials were broken/opened.

• Brand Name: VERIFY V24 SCBI
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): STERIS BIOLOGICAL OPERATIONS; 9325 pinecone dr; mentor OH 44060
• Manufacturer (Section G): STERIS BIOLOGICAL OPERATIONS; 9325 pinecone dr.; mentor OH 44060
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 6153003
• MDR Text Key: 61697965
• Report Number: 3004080920-2016-00016
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Lot Number: 161217E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2016
• Initial Date FDA Received: 12/07/2016
• 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