MAUDE Adverse Event Report: CONMED CORPORATION WANG CYTOLOGY NEEDLE; WANG NEEDLE

Catalog Number	SW-221
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/23/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of this filing, the device has not been received.Once received, the evaluation will be completed and a supplemental and final report will be filed.Device to be returned.
Event or Problem Description
The user facility reported that the sw-221 wang cytology needle was received with the pouch not sealed.To date no further information has been received.
Additional Manufacturer Narrative
One open sw-221 wang cytology needle was returned to conmed quality assurance laboratory for evaluation.The device was examined and a visual inspection noted the pouch has what appears to be good seal transfer across the open area of the pouch.The device was forwarded to packaging engineering for an expert evaluation.The results were as follows.It is obvious to confirm the pouch is open thus affecting the integrity of the package.It is also obvious to say that the manufacturing and vendor (2 side) seals were affected.Both, vendor and manufacturing seals meet conmed's visual requirements and there is no indication of a sealing defect or problem at all.The seals look uniform with good adhesive transfer across the entire sealing surface for the pouch.The product inside this pouch is extremely light and does not have any weight that can cause the pouch to open the way it did during normal transit conditions.Also there are no seal creeps at all, which is an indication that the product may have penetrated through the seals thus causing the pouch to open.The device was manufactured 15-sep-2015.A review of the device history record for this lot found no related discrepancies during the manufacturing process and no non-conformances regarding the product's identity, quality, safety, effectiveness or performance that could have caused or contributed to this reported incident.Of the lot containing 10 units, there were no other similar complaints received.A 2-year review of product history for this device family revealed a total of 1 complaint for "defective seal." during this same 2-year time frame, over (b)(4) units were sold worldwide, making the occurrence rate for this failure mode (b)(4).To date, there have been no patient long term effects reported regarding any reported incidents.(b)(4) guidelines state: - sterile items that are not opened, dispensed and transferred by methods that maintain sterility and integrity may contaminate the sterile field.- perioperative team members should inspect sterile items for proper processing, packaging, and package integrity immediately before presentation to the sterile field.- inspecting items before presentation to the sterile field helps verify that conditions required for sterility have been met and helps prevent microbial contamination that might occur if the integrity of the container has been breached and the item is placed on the sterile field.Correction to d4: the expiration date from 09/15/2020 to 09/13/2020 at stated on the device label.

• Brand Name: WANG CYTOLOGY NEEDLE
• Common Device Name: WANG NEEDLE
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6033448
• Report Number: 1320894-2016-00128
• Device Sequence Number: 19042237
• Product Code: EOQ
• UDI-Device Identifier: 00653405052695
• UDI-Public: (01)00653405052695(17)200913(30)1(10)201509151
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K914181
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2016

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
• Operator of Device: No Information
• Device Expiration Date: 09/13/2020
• Device Catalogue Number: SW-221
• Device Lot Number: 201509151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/23/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2016
• Supplement Report FDA Received Date: 11/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other