MAUDE Adverse Event Report: CONMED CORPORATION 1/4" X 6' SURGICAL TUBING; 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
Two (2) 0036280 1/4" x 6' suction tubing packages were returned for evaluation of "defective seal." the packaging lab results showed the samples failed the visual test.Both packages were found to be compromised due to an open pouch seal with less than 1/4" open on the chevron side of the pouch, therefore, this complaint is confirmed.The devices were manufactured 24-november-2015.A review of the device history record for this lot found no discrepancies during the manufacturing process and no non-conformances regarding this product's identity, quality, safety, effectiveness or performance that could have caused or contributed to this event.Of the lot containing (b)(4) units there were no other similar complaints received.A 2-year history of this device family revealed a total of (b)(4) complaints involving (b)(4) devices related to this failure mode and product.(b)(4).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.However, to prevent future recurrences, an investigation has been initiated to address this issue.
Event or Problem Description
The distributor in (b)(4) reported that during receiving and inspection of incoming products, 2 packages containing 1/4" x 6' suction tubing was discovered with "defective seal." 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.This report is being filed based on the potential for injury with recurrence.

• Brand Name: 1/4" X 6' SURGICAL TUBING
• Common Device Name: SUCTION TUBING
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6248860
• Report Number: 3007305485-2017-00012
• Device Sequence Number: 551457
• 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): 01/13/2017

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: 11/22/2020
• Device Catalogue Number: 0036280
• Device Lot Number: 201511244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2016
• Initial Report FDA Received Date: 01/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1