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

Catalog Number 550-000-003

Device Problems Burst Container or Vessel (1074); Defective Device (2588); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2013

Event Type  malfunction  

Event Description

Bag ripped from the seam while the specimen was being removed from the patient.Physician and nurses had to work to regrip the bag and properly remove the specimen.

Manufacturer Narrative

The product identified is supplied to deroyal from (b)(4).The vendor identified was issued (b)(4).Additional follow ups were performed on (b)(4) 2013; and the updated response was received on (b)(4) 2013.Within the vendor's response, it was 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)(6) has confirmed via email that the new bag has met all outstanding complaints.In addition, the qc complaint specialist created a time line of events has been completed to provide additional details for the additional follow up communication and responses by the vendor.(b)(4).Updated: due to a review of the complaint and subsequent decision that the reported issue requires an mdr, the call has been re-opened per deroyal regulatory department.The initial investigation details communication between the deroyal and the vendor of the device, (b)(4).Correction: no additional corrections have been taken as a result of the re-opening of the call.Root cause analysis: no changes have been made to the initial investigations root cause determination (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 heat 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)(6) was able to see the new style bag at a diagnostic lab on (b)(6) 2013.The new pouch is now stitched to ensure that there can be no heat sealer issue.Updated: deroyal has determined to issue a recall for the finished good.This information has been communicated to te qc complaint specialist on 04/14/2015 via email.The email will be retained within the qc complaint specialist email file.Updated: deroyal has taken additional actions with the executive decision to discontinue to distribute the (b)(4) product line.Evidence of this decision was communicated to the qc complaint specialist via an email received on 02/10/2015 and will be retained within the qc complaint specialist email file.

• Brand Name: MEDIUM SPECIMEN RETRIEVAL BAG, 100MMX150
• Manufacturer (Section D): GENICON; 6869 stapoint ct., ste, 114; winter park FL 32792
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653622333
• MDR Report Key: 4717924
• MDR Text Key: 18258285
• Report Number: 1060680-2015-00017
• Device Sequence Number: 1
• Product Code: FMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 550-000-003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/30/2013
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/29/2013
• Event Location: Hospital
• Date Manufacturer Received: 04/29/2013
• 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
• Removal/Correction Number: TBD
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention