MAUDE Adverse Event Report: JOIMAX GMBH SINGLE USE TUBING SET FOR VERSICON; LAVAGE JET,

Model Number	JTSB350D
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/07/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was discarded by the user facility and was not available for evaluation, therefore a definitive root cause could not be established to confirm or deny a device malfunction.A review of similar complaints revealed the root cause as use error where the luer-lock connector was not tightened appropriately.There were no other complaints of leaks from this manufacturing lot.The device history records for this manufacturing lot were reviewed and there were no discrepancies or unusual findings that relate to the reported event.(b)(4).
Event or Problem Description
Joimax became aware of a maude report filed by a healthcare facility alleging that during preparation for surgery the versicon tubing set leaked.The facility reports that the leaking tubing was removed from the field, discarded, and replaced with a new tubing set with no further issues.There was no report of injury.Because the device was not available for analysis the investigation was inconclusive as to whether the event was attributed to device malfunction or use error.

• Brand Name: SINGLE USE TUBING SET FOR VERSICON
• Common Device Name: LAVAGE JET,
• Manufacturer (Section D): JOIMAX GMBH; amalienbadstrasse 41; raumfabrik 61; karlsruhe, 76227 ; GM 76227
• MDR Report Key: 7683295
• Report Number: 3005083075-2018-00002
• Device Sequence Number: 11167492
• Product Code: FQH
• UDI-Device Identifier: 04250337105640
• UDI-Public: 04250337105640
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: 510K EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 07/12/2018

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 Expiration Date: 05/30/2020
• Device Model Number: JTSB350D
• Device Catalogue Number: JTSB350D
• Device Lot Number: 04052015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2016
• Initial Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR