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 Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conmed corporation received six (6) "unopened" packages containing the 1/4" x 6' suction tubing for evaluation.Visual examination of the returned packages found all six (6) packages with full seal disruptions occurring in the final manufacturing seals.In all of the returned packages, there is evidence that the device, suction tubing, was sealed within the sterile seal of the package.In those areas adhesive transfer to the poly material showing that a full seal existed is missing due to the product obstructing the seal.The devices were transferred to packaging engineering for evaluation and testing.Only two (2) of these devices were confirmed that the seal failed the dye leak test on (b)(6) 2016.This lot was manufactured on 21-dec-2015.A review of the manufacturing documents from the dhr/lhr has verified the devices were produced according to current and approved procedures and material specifications.Non-conformances regarding the product's identity, quality, safety, effectiveness or performance were not identified during manufacture.In these instances, preliminary investigation revealed that the most probable cause of the seal disruptions appeared to be related to the device being within the sterile seal area during the final manufacturing sealing process.Of the lot containing (b)(4) units, there has only been one (1) other similar complaint received.A two (2) year review of product history for this device family showed a total of (b)(4) complaints involving (b)(4) devices including this complaint regarding insufficient heat seals, with (b)(4) devices confirmed and (b)(4) devices still pending evaluation.During this same two (2) year time frame, over (b)(4) units were sold worldwide, making the occurrence rate for this reported failure mode (b)(4) percent.The reported packaging anomalies were obvious to the distributor and therefore prompted the return of the devices for evaluation and replacement.To date, there have been no serious injuries or death related to this reported problem.Nonetheless, to prevent future recurrences, an investigation, capa (b)(4), has been opened to address this issue.As with all medical devices, examination of packaging occurs multiple times prior to use (shipping/receiving, distribution, storage and prior to use).In addition, good clinical practice would include examination and verification of the product and its original packaging to ensure both are intact.If the product and its packaging have been opened/damaged or altered, do not use the product and contact the manufacturer immediately.
Event or Problem Description
The distributor in (b)(4) reported that during receiving and inspection of incoming products, six (6) packages containing one (1) each 1/4" x 6' suction tubing were discovered with "insufficient heat seal." in this instance, 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 an end-user.

• 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: 6192092
• Report Number: 3007216334-2016-00158
• Device Sequence Number: 993813
• 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,other
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/20/2016

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: 12/19/2020
• Device Catalogue Number: 0037860
• Device Lot Number: 201512215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/23/2016
• Initial Report FDA Received Date: 12/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1