MAUDE Adverse Event Report: CONMED CORPORATION POOLE SUCTION INSTRUMENT; TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Catalog Number	0035040
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) poole suction instrument was returned for evaluation of "insufficient heatseal." the packaging lab results showed an opening in the seal area.Proper adhesive transfer was observed in the open seal area, indicating that the seal was initially properly formed.The open seal may have been created by the product pushing through the seal during shipping and handling.This device was manufactured 16-november-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 only this one complaint has been received for this lot product and event description.A 2-year review of device family history revealed 12 complaints involving 15 devices of which 13 were confirmed or are pending evaluation of "insufficient heatseal." (b)(4).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.The reported packaging anomalies were obvious to the distributor, prompting return of the devices for evaluation.Good clinical practice would include examination and verification of the product and its original packaging to ensure both are intact.This package was completely open and would prompt the end-user to discard and obtain a sterile package.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
As reported by the distributor in (b)(4), during receiving and inspection of incoming products, 1 package containing a poole suction instrument was discovered to have "insufficient heatseal." there was no patient involvement in 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: POOLE SUCTION INSTRUMENT
• Common Device Name: TUBE, ASPIRATING, FLEXIBLE, CONNECTING
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6421917
• Report Number: 1320894-2017-00060
• Device Sequence Number: 16294473
• Product Code: BYY
• UDI-Device Identifier: 00653405000382
• UDI-Public: (01)00653405000382
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K780724
• 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): 03/21/2017

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: 11/14/2020
• Device Catalogue Number: 0035040
• Device Lot Number: 201511161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2017
• Initial Report FDA Received Date: 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1