MAUDE Adverse Event Report: CONMED CORPORATION 10 FRENCH FRAZIER SUCTION INSTRUMENT

Catalog Number	0033100
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conmed corporation received 2 "unopened" packages containing the 10 french frazier suction instruments for evaluation.Visual examination of the returned packages found the tip of one device is protruding through the final manufacturing seal.The second device was found to have a seal width out of specification.Both devices were transferred to the packaging lab for evaluation.The first device was confirmed as unsterile failing the dye leak testing on (b)(4) 2016.The second device passed the dye leak test with no breach of sterility.This failure mode is addressed in the risk document.This lot was manufactured on 23-nov-2015.Of the lot containing (b)(4) pieces this is the only reported seal issue.A review of the device history record for this lot found no ncrs and no note of discrepancies during the manufacturing process.A 2 year review of product history for this device family showed a total of 10 complaints involving 12 devices including this complaint regarding insufficient heat seals.(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.Nonetheless, to prevent future recurrences, an investigation has been opened to address this issue.This information has been forwarded to the investigation owner.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, 2 packages, each containing one 10 french frazier suction instrument, 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 an end-user.

• Brand Name: 10 FRENCH FRAZIER SUCTION INSTRUMENT
• Common Device Name: FRAZIER SUCTION INSTRUMENT
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6015323
• Report Number: 3007305485-2016-00120
• Device Sequence Number: 10782518
• Product Code: GCX
• UDI-Device Identifier: 00653405000382
• UDI-Public: (01)00653405000382
• 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): 09/20/2016

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: 11/23/2020
• Device Catalogue Number: 0033100
• Device Lot Number: 201511231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/20/2016
• Initial Report FDA Received Date: 10/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1