MAUDE Adverse Event Report: CONMED CORPORATION POOLE SUCTION WITH REMOVABLE SHEATH; TUBE, ASPIRATING, FLEXIBLE, CONNECTING

Catalog Number	0035040
Medical Device Problem Code	Device Packaging Compromised (2916)
Health Effect - Clinical Code	Not Applicable (3189)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) 0035040 poole suction instrument with removable sheath was returned to conmed for evaluation of "the seal of the sterile pouch was breached." during visual inspection it was concluded that the device was in the seal area during the sealing process of the form, fill and seal machine.This open seal resulted in a breach of sterility therefore this complaint is confirmed.This device was manufactured on 10/17/2016.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 (b)(4) complaint has been received for "breach of sterile pouch." a 2-year review of product family history has revealed (b)(4) complaints involving (b)(4) devices, of which (b)(4) were confirmed for this reported problem.During this same 2-year time frame over (b)(4) devices were sold worldwide making the occurrence rate for this failure mode (b)(4) percent.The reported packaging anomaly was obvious to the distributor, prompting return of the device for evaluation and replacement.This failure mode has been addressed in the risk documents.To date, there have been no long term adverse effects from any of these reported incidents however, an investigation has been initiated to prevent further occurrences.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)(6), one (1) poole suction instrument with removable sheath was discovered to have an "insufficient heatseal or blister pack." 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 WITH REMOVABLE SHEATH
• Common Device Name: TUBE, ASPIRATING, FLEXIBLE, CONNECTING
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 6566605
• Report Number: 1320894-2017-00112
• Device Sequence Number: 13691501
• Product Code: BYY
• UDI-Device Identifier: 10653405000389
• UDI-Public: (01)10653405000389(17)211016(10)201610171
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2017

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: 10/16/2021
• Device Catalogue Number: 0035040
• Device Lot Number: 201610171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1