MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA EMT AUSTRALIA "MISTAWAY" SOFT PAK REG. FOG; ANTI-FOG

Model Number EMT-3100

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 03/08/2018

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that a mistaway sponge was found in the seal of a pouch.The actual device was not returned for evaluation.The manufacturing lot number along with photographic evidence was provided for review.A review of the photo confirmed the issue from the distributor.Analysis of the finished good lot number 133847 was reviewed.No non-conformance's were noted during the manufacturing process.According to the manufacturing process, these parts are manually loaded into recessed pockets on a packaging machine per specified work instructions.If incorrectly loaded or not orientated properly, the product interferes with the sealing process.Therefore a likely root cause for the seal issue may be attributed to an operator error.Production supervisors were notified of this issue.Based on this information, no further action is required.

Event Description

Aspen surgical received a report from the distributor indicating that a mistaway sponge was found in the seal of a pouch.The item was not in use.No injury/death was reported.This report was filed in our complaint handling system as (b)(4).

• Brand Name: EMT AUSTRALIA "MISTAWAY" SOFT PAK REG. FOG
• Type of Device: ANTI-FOG
• Manufacturer (Section D): ASPEN SURGICAL PRODUCTS, CALEDONIA; 6945 southbelt dr. s.e.; caledonia MI 49316
• Manufacturer (Section G): SAME AS ABOVE
• Manufacturer Contact: jordan hackert ; 6945 southbelt dr. s.e.; caledonia, MI 49316 ; 6165367508
• MDR Report Key: 7402239
• MDR Text Key: 105255755
• Report Number: 1836161-2018-00038
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K932449
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Model Number: EMT-3100
• Device Lot Number: 133847
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2017
• 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