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

Catalog Number	0036280
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) 0036280 1/4" x 6' suction tubing was returned for evaluation of "insufficient heatseal." a visual inspection revealed that the package had an open pouch with no adhesive transfer.The packaging lab evaluation showed the device was not in the seal area during the sealing process of the form, fill, and seal machine but close enough to affect the ability of the machine to create a seal.It can be concluded that the device was not caught in the seal area because there was no adhesive transfer apparent on the tubing.This complaint is confirmed for breach of sterility.The device was manufactured 1-september-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 14,750 units only this one complaint has been received.A 2-year review of device family history revealed 30 complaints involving 74 devices of which 68 were confirmed or pending evaluation of "insufficient heatseal." 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.This failure mode has been addressed in the risk documents.To date, there have been no long term adverse effects reported for any of these reported problems, however, an investigation has been initiated to prevent further occurrences.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.This package was completely open and would prompt the end-user to discard and obtain a sterile package.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), one (1) 1/4" x 6' suction tubing package was discovered to have an "insufficient heatseal." 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: 6440363
• Report Number: 3007305485-2017-00073
• Device Sequence Number: 512081
• Product Code: BYY
• UDI-Device Identifier: 00653405000467
• UDI-Public: (01)00653405000467
• 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): 03/28/2017

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: 08/30/2020
• Device Catalogue Number: 0036280
• Device Lot Number: 201509014
• 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: 03/14/2017
• Initial Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1