MAUDE Adverse Event Report: CONMED CORPORATION 1/4 INCH X 10 FOOT SUCTION TUBING

Catalog Number	0036290
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conmed corporation received two (2) "unopened" packages containing the 1/4" x 10' suction tubing for evaluation.Visual examination of the returned packages found one (1) package with full seal disruption occurring in the final manufacturing seal.In this instance, there is evidence that the device, suction tubing, was sealed within the sterile seal of the package.In that area 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.One (1) of the two (2) devices was confirmed that the seal failed the dye leak test on (b)(6) 2016.This lot was manufactured on 30-apr-2015.A review of the device history record for this lot found no ncrs and no note of discrepancies during the manufacturing process.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 (b)(4) units from this lot shipped to the distributor, there were only these two (2) units found with "insufficient heat seal" discovered by the distributor inspector, who performed 100% incoming inspection of all devices.Of these two (2) devices only one (1) was confirmed for a non-intact sterile barrier.In addition, of the lot containing (b)(4) units, there are no other similar complaints received.A two (2) year review of product history for this device family showed a total of fifty six (56) complaints involving one hundred sixteen (116) devices including this complaint regarding insufficient heat seals.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 has been opened to address this issue.These devices were manufactured prior to the opening of that investigation.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)(6) reported that during receiving and inspection of incoming products, two (2) packages containing 1/4" x10' suction tubing were discovered with "insufficient heat seal." one of these returned devices exhibited full open seal disruption in the sterile barrier 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 10 FOOT SUCTION TUBING
• Common Device Name: SUCTION TUBING
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 5588007
• Report Number: 3007305485-2016-00039
• Device Sequence Number: 49691
• Product Code: BYY
• UDI-Device Identifier: 00653405000474
• UDI-Public: (01)00653405000474
• 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): 04/12/2016

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: 04/28/2020
• Device Catalogue Number: 0036290
• Device Lot Number: 201503244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2016
• Initial Report FDA Received Date: 04/20/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1