MAUDE Adverse Event Report: W.O.M. WORLD OF MEDICINE GMBH PNEUMOCLEAR HEATED HIGH-FLOW TUBE SET; TUBE SET FOR INSUFFLATION, DISPOSABLE

Model Number	0620050200
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/30/2018
Type of Reportable Event	Malfunction
Event or Problem Description
During a procedure, a disposable heated high-flow tube set (ref# (b)(4)) was used which showed a kinking right after the interface for connection to the insufflator.Afterwards, a sales representative checked the facility´s inventory of packaged tube sets and found other tube sets also showed this kinking.It was reported that 4 packaged tube sets were kinked in such a way that the prongs of the connection interface now face outward towards the packaging and have led to punctures of the pouch packaging, thus leading to impairment of the sterile barrier.

• Brand Name: PNEUMOCLEAR HEATED HIGH-FLOW TUBE SET
• Common Device Name: TUBE SET FOR INSUFFLATION, DISPOSABLE
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 8390527
• Report Number: 3002914049-2019-00001
• Device Sequence Number: 13906006
• Product Code: HIF
• UDI-Device Identifier: 04056702001568
• UDI-Public: 04056702001568
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K170784
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 09/28/2018

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: Health Professional
• Device Model Number: 0620050200
• Device Catalogue Number: 0620050200
• Device Lot Number: 4012599
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1