MAUDE Adverse Event Report: CONMED CORPORATION 1/4 INCH X 6 FOOT SUCTION TUBING

Catalog Number	0037860
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conmed corporation received four (4) "unopened" packages containing 1/4" x 6' suction tubing for evaluation.Visual examination by the packaging lab engineer on (b)(6) 2017 revealed sample 1 had an open pouch with no adhesive transfer.The device was in the seal area and affected the ability of the machine to create a seal.Although samples 2 and 3 had an adhesive transfer less than 1/4" and the devices appear to have been in the seal area during the sealing process, both packages passed the dye leak test and therefore had no breach of sterility.Sample 4 was found to have a cut near the side of the pouch.The cut resulted in a failure to pass the dye leak test and therefore breach of sterility.The cut was examined under microscope and was found to have a sharp thin cut possibly created by the sharp rib of the male connector.Due to the breach of sterility found in sample 1 and 4, this complaint is confirmed.This lot was manufactured on 15-may-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 (b)(4) units, there are no similar complaints received.A two (2) year review of product history for this device family showed a total of thirty (30) complaints involving 74 devices (68 devices with confirmations or pending evaluation) regarding insufficient heat seals.(b)(4).The reported packaging anomalies were obvious to the distributor and therefore prompted the return of the device for evaluation and replacement.This failure mode is address in the risk documents.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.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, four (4) packages containing one (1) each 1/4" x 6' suction tubing were discovered with "insufficient heat 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 6 FOOT SUCTION TUBING
• Common Device Name: SUCTION TUBING
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6457119
• Report Number: 3007305485-2017-00079
• Device Sequence Number: 562995
• Product Code: BYY
• UDI-Device Identifier: 00653405000627
• UDI-Public: (01)00653405000627
• 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
• Type of Report: Initial
• Report Date (Section B): 04/04/2017

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: 05/13/2020
• Device Catalogue Number: 0037860
• Device Lot Number: 201505154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2017
• Initial Report FDA Received Date: 04/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1