MAUDE Adverse Event Report: GENICON MEDIUM SPECIMEN RETRIEVAL BAG, 100MMX150; CONTAINER, SPECIMEN, STERILE

Catalog Number 550-000-003

Device Problems Unraveled Material (1664); Activation, Positioning or Separation Problem (2906); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/21/2010

Event Type  malfunction  

Event Description

When the item was inserted into the pt, surgeon went to deploy the bag.He said the bag "fell apart" upon deployment.Material's manager, was then called into case and replaced the defective bag with a new one.

Manufacturer Narrative

Investigation findings: the product is a vendor supplied product.The qfi report review identified sales info, and for similar reports.Deroyal has sold (b)(4) cases of the finished good from 2011 to 2013.No similar reports were found for the product, "falling apart upon deployment".During the course of the investigation (b)(4) supplied a performance eval of the product.An initial scar response was provided, on 04/03/2013, indicating the investigation is ongoing.The vendor has been identified as (b)(4).(b)(4) was issued to the vendor on 08/26/2013.Follow ups were performed on 09/04/2013; on 09/10/2013; on 09/12/2013; and the updated response was received on 09/16/2013.Within the vendor's response it is indicated that, "the new revisions will be tested using the same test format as (b)(4) to ensure that the change has been implemented correctly.Added 09/16/2013 - (b)(4) is still in the verification phase as we are still testing the new style bag to our quality standards but mr.(b)(4) has confirmed via email that the new bag has met all outstanding complaints.Correction: as per the customer's request a replacement was shipped on order# (b)(4).Root cause analysis: (b)(4): the root cause appears to be along the seam of the pouch where it is possible that the heat sealer is not properly sealing the pouch.The cause for the heart sealer failure has not been determined yet.Added 09/16/2013- the decision was made to source a pouch that was made of a different material that provided a stronger seal than our current product.The new material is also impermeable.(b)(4) was able to see the new style bag at a diagnostic lab on 09/11/2013.The new pouch is now stitched to ensure there can be no heat sealer issue.Corrective action and/or systemic correction action taken: (b)(4): ongoing- we are investigating the heat sealer and hydrophobic coating.A rep from the coating supplier is meeting with our cto next week to discuss options.If you hypothesis is correct, we will adjust the hydrophobic coating and the issue will no longer occur.This will not affect the shelf life of the product and all tests that are required will be completed.Added 09/16/2013- after extensive review a different material and pouch were developed.(b)(4) (deroyal) was able to evaluate the bag and provide this info, "the product is not impermeable, and the stitching or weld is being reinforced but is acceptable in the field." preventive action: (b)(4): added 09/16/2013- (b)(4) held a diagnostic lab prior to releasing the new product that allowed multiple companies to use the product and provide feedback.We will also provide, along with the help of our distributors, more hand on in-service and follow-up to ensure proper use of the product.This report is being filed due to a retrospective review of complaints.This complaint has been re-opened for further investigation.A supplemental report will be filed if further investigation provides info which changes the content of this report.

• Brand Name: MEDIUM SPECIMEN RETRIEVAL BAG, 100MMX150
• Type of Device: CONTAINER, SPECIMEN, STERILE
• Manufacturer (Section D): GENICON; 6869 stapoint st; ste 114; winter park FL 32792
• Manufacturer Contact: 200 debusk ln; powell, TN 37849 ; 8653622333
• MDR Report Key: 4749212
• MDR Text Key: 5771849
• Report Number: 1060680-2015-00018
• Device Sequence Number: 1
• Product Code: FMH
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 550-000-003
• Device Lot Number: 1304QDA403 INCORRECT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/21/2013
• Event Location: Hospital
• Date Manufacturer Received: 08/21/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: TBD
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention