MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA BATRIK SOFTPACK ANTI-FOG SOLUTION W/SPONGE

Model Number 99-GOLFF

Device Problem Structural Problem (2506)

Patient Problem No Patient Involvement (2645)

Event Date 01/20/2020

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor indicating that product was found with seal issues.The actual device was returned for evaluation.The manufacturing lot number along with samples were provided for review.The distributor indicated that the defects were found during incoming inspection.A review of the samples confirmed the issue from the distributor.Analysis of the finished good lot number 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 defect may be attributed to an operator error.The ifu which is received with the product, along with the pouch label, identifies this failure mode with the symbol "do not use if package is damaged".This indicates that the device should not be used if the products sterile barrier system or its packaging is compromised.Additionally, production supervisors and operations 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 batrick anti-fog was discovered with a sealing issue.The item was not in use.No injury/death was reported.This report was filed in our complaint handling system as number (b)(4).

• Brand Name: BATRIK SOFTPACK ANTI-FOG SOLUTION W/SPONGE
• 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: 9707074
• MDR Text Key: 191438922
• Report Number: 1836161-2020-00008
• Device Sequence Number: 1
• Product Code: OCT
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 99-GOLFF
• Device Lot Number: 205487
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2020
• 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