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

Device Problems Nonstandard Device (1420); Tear, Rip or Hole in Device Packaging (2385); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/30/2018

Event Type  malfunction  

Event 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
• Type of Device: TUBE SET FOR INSUFFLATION, DISPOSABLE
• Manufacturer (Section D): W.O.M. WORLD OF MEDICINE GMBH; salzufer 8; berlin, 10587 ; GM 10587
• Manufacturer Contact: soeren markworth ; salzufer 8; berlin, 10587 ; GM 10587
• MDR Report Key: 8390527
• MDR Text Key: 138241967
• Report Number: 3002914049-2019-00001
• Device Sequence Number: 1
• Product Code: HIF
• UDI-Device Identifier: 04056702001568
• UDI-Public: 04056702001568
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170784
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 0620050200
• Device Catalogue Number: 0620050200
• Device Lot Number: 4012599
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/30/2018
• Initial Date FDA Received: 03/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1