MAUDE Adverse Event Report: CONMED CORPORATION 1/4" X 6' SUCTION TUBING; TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Catalog Number	0037860
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Eight (8) packages of 1/4" x 6' suction tubing packages were received by conmed for evaluation of "insufficient heatseal or blister pack." visual inspection revealed that samples 1 and 2 had open seals with no adhesive transfer.The devices were not in the seal area during the sealing process of the form and fill seal machine but were close enough to affect the ability of the machine to create a seal.This open seal created a breach of sterility and therefore the complaint is confirmed for sample 1 and 2.When visually inspecting sample 3, the seal transfer was found to be less than 1/4".A dye leak test was performed which confirmed that there was an open seal on this pouch resulting in a breach of sterility and therefore confirmed.A visual inspection of samples 4 through 8 found the seal transfer to be less than 1/4" however a dye leak test revealed that there was no breach in sterility.These devices were manufactured 21-december-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.Of the lot containing (b)(4) units there have been 3 complaints including this one for "insufficient heatseal." a 2-year review of device family history revealed 30 complaints involving 74 devices of which 68 were confirmed or are pending evaluation.During this same 2-year time frame over (b)(4) units were sold worldwide making the occurrence rate for this failure mode (b)(4) percent.The reported packaging anomaly was obvious to the distributor, prompting return of the device for evaluation and replacement.This failure mode has been addressed in the risk documents.To date, there have been no long term adverse effects from any of these reported incidents.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
As reported by the distributor in (b)(4) , eight (8) 0037860 1/4" x 6' suction tubing packages were discovered to have an "insufficient heatseal or blister pack." there was no patient involvement in this reported problem, as the packaging anomaly was discovered during inspection at the distributor facility prior to distribution to an end-user.This report is being filed based on the potential for injury with recurrence.

• Brand Name: 1/4" X 6' SUCTION TUBING
• Common Device Name: TUBE, ASPIRATING, FLEXIBLE, CONNECTING
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6446485
• Report Number: 3007305485-2017-00076
• Device Sequence Number: 875109
• Product Code: BYY
• UDI-Device Identifier: 00653405000627
• UDI-Public: (01)00653405000627
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: 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
• Report Date (Section B): 03/30/2017

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: 03/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2017
• Initial Report FDA Received Date: 03/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1