MAUDE Adverse Event Report: ASPEN SURGICAL PRODUCTS, CALEDONIA MEDLINE RIGID LIGHT HANDLE COVER, STERILE

Model Number MD-R2

Device Problem Unsealed Device Packaging (1444)

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

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

Aspen surgical received a report from the distributor that product was found with seal issues.The actual device was returned for evaluation.The manufacturing lot number was available for review.A review of the sample confirmed the reported issue for the light handle being packaged in the seal of the pouch.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 parts in the seal can be attributed to an operator error.Operations and supervisors were notified of this issue during the daily update meetings.Based on this information, no further action is required.

Event Description

Aspen surgical received a report from the distributor indicating that a rigid light handle cover packaging was found with seal issues.The item was not in use.No injury/death was reported.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: MEDLINE RIGID LIGHT HANDLE COVER, STERILE
• Type of Device: LIGHT HANDLE
• 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: 8124040
• MDR Text Key: 129313747
• Report Number: 1836161-2018-00124
• Device Sequence Number: 1
• Product Code: FTA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020304
• 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: 11/05/2018

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 Model Number: MD-R2
• Device Lot Number: 156457
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 12/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2018
• 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