MAUDE Adverse Event Report: CONMED CORPORATION 1/4 INCH X 6 FOOT SUCTION TUBING

Catalog Number	0037860
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Codes	No Patient Involvement (2645); Not Applicable (3189)
Date of Event	09/29/2016
Type of Reportable Event	Malfunction
Event or Problem Description
The distributor in (b)(6) reported that during receiving and inspection of incoming products, 4 packages containing 1/4" x 6' suction tubing was discovered with "insufficient heat seal." there was no patient involvement with this reported problem, as the packaging anomaly was discovered during inspection at the distributor facility prior to distribution to the end-user.These devices were manufactured 21-dec-2015.Of the lot containing 4,800 units there were no other similar complaints received for this item and lot number combination.A review of the device history record for this lot has verified that the devices were produced according to current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety and effectiveness or performance were not identified during manufacture.A 2-year review of product history for this device family revealed 49 complaints involving 78 confirmed devices for this similar complaint "insufficient heat seal." during this same 2-year time frame, over 13,196,585 units were sold worldwide, making this occurrence rate for this failure 0.0005 percent.As of this filing, the device has not been received.Once received, the evaluation will be completed and a supplemental and final will be filed.
Additional Manufacturer Narrative
Four (4) packages containing goldline rocker, holster, and ultraclean electrodes were returned to conmed and evaluated by packaging engineering for evaluation of "insufficient heatseal with pouch or blister pack." visual inspection revealed that samples 1 and 3 had less than 1/4" seal transfer in the area during the sealing process of the fill and form machine.After performing the dye leak testing it was confirmed that there was not an open seal on these pouches and therefore no breach in sterility has occurred.During visual inspection of sample 2 it was found that the seal transfer was less than 1/4." this device failed the dye leak test, confirming that there was an open seal (channel) and thus a breach in sterility.Visual inspection of sample 4 revealed that the pouch was open due to part of the device being in the seal area during the sealing process and therefore resulted in a breach of sterility.This failure mode is addressed in the risk documents.To date, there have been no serious injuries or deaths related to this reported problem.This reported issue has been determined to be operator error and a performance qualification is in progress to validate a new position of tubing to avoid connectors being caught in the sealing area.This issue will continue to be monitored through the complaint system.The reported packaging anomalies were obvious to the distributor, prompting return of the devices for evaluation.Good clinical practice would include examination and verification of the product and its original packaging to ensure both are intact before use.Correction: corrected report type from adverse event to product problem.Corrected expiration date from 12/21/2020 to 12/19/2020.Corrected from: device history 2-year review product family corrected from: a 2-year review of product history for this device family revealed 49 complaints involving 78 confirmed devices for this similar complaint "insufficient heat seal." (b)(4).Corrected to: a 2-year review of product history for this device family revealed 32 complaints involving 79 devices, of which 52 were confirmed and 19 devices are pending evaluation for this similar complaint of "insufficient heat seal with pouch or blister pack." (b)(4).The numbers reflected in the original describe event or problem included the entire product family and not all of these devices are packaged in the same manner.This corrected data more accurately and conservatively reflects only the devices in this family that are packaged on the same fill and form machine.

• Brand Name: 1/4 INCH X 6 FOOT SUCTION TUBING
• Common Device Name: SUCTION TUBING
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6095914
• Report Number: 3007305485-2016-00136
• Device Sequence Number: 839803
• Product Code: BYY
• UDI-Device Identifier: 00653405000627
• UDI-Public: (01)00653405000627
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P/A EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 12/19/2020
• Device Catalogue Number: 0037860
• Device Lot Number: 201512215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/11/2016
• Supplement Report FDA Received Date: 03/01/2017
• 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