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

Catalog Number	0036280
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 one (1) "unopened" package containing the 1/4" x 6' suction tubing for evaluation.Visual examination of the returned package found the package open with no adhesive transfer.During the sealing process of this device, the product was oriented in such a way as to affect the machine's ability to create a seal.The device was not caught in the seal area, but did result in an open seal and therefore breach of sterility.This lot was manufactured on 14-sep-2016.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 are no similar complaints 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 or still pending evaluation.(b)(4).The reported packaging anomaly was obvious to the distributor and therefore prompted the return of the device 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, (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, one (1) package containing one (1) each 1/4" x 6' suction tubing was 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: 6299011
• Report Number: 3007305485-2017-00024
• Device Sequence Number: 810764
• Product Code: BYY
• UDI-Device Identifier: 10653405000464
• UDI-Public: (01)10653405000464
• 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): 02/02/2017

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: 09/13/2021
• Device Catalogue Number: 0036280
• Device Lot Number: 201609145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2017
• Initial Report FDA Received Date: 02/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1