MAUDE Adverse Event Report: CONMED CORPORATION 1/4" X 12' SURGICAL TUBING; SUCTION TUBING

Catalog Number 0036550

Device Problem Unsealed Device Packaging (1444)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Manufacturer Narrative

One (1) 0036550 1/4" x 12' suction tubing package was returned to conmed for evaluation of "insufficient heatseal." the packaging test results revealed an open seal with adhesive transfer less than 1/4 inch, therefore this complaint is confirmed.The device was manufactured 1-july-2016.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 have been 2 complaints related to this reported complaint of "insufficient heatseal." a 2-year history of this device family revealed a total of (b)(4) complaints involving (b)(4) devices of which (b)(4) have been confirmed or pending evaluation for this failure mode and product.During this same 2-year time frame, over (b)(4) units were sold making this failure rate (b)(4) percent.This failure mode is addressed in the fmea and the safety risk has been found to be acceptable.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 Description

The distributor in (b)(4) reported that during receiving and inspection of incoming products, 1package containing 1/4" x 12' suction tubing was discovered with "insufficient heat 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 the end-user.This report is being filed based on the potential for injury with recurrence.

• Brand Name: 1/4" X 12' SURGICAL TUBING
• Type of Device: SUCTION TUBING
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• Manufacturer (Section G): CONSOLIDATED MEDICAL EQUIPMENT COMPANY; ave. alejandro dumas no. 11321; complejo industrial chihuahua; chihuahua, chihuahua CP 11 36; MX CP 1136
• Manufacturer Contact: kimber boss ; 525 french road; utica, NY 13502-5994 ; 3156243441
• MDR Report Key: 6294300
• MDR Text Key: 66327123
• Report Number: 3007305485-2017-00021
• Device Sequence Number: 1
• Product Code: BYY
• UDI-Device Identifier: 00653405000528
• UDI-Public: (01)00653405000528
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P/A EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 0036550
• Device Lot Number: 201607014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1