MAUDE Adverse Event Report: BOEHRINGER LABORATORIES BOEHRINGER LOCKING CABLE; SUCTION REGULATOR TETHER

Model Number	9143
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/09/2016
Event or Problem Description
This report is being submitted by boehringer laboratories (manufacturer) in order to provide information not included (model, lot # etc.) on user facility report (b)(4) (copy included).A patient owned, electronic service was being plugged into a wall outlet in a hospital room.A suction regulator tether was inadvertently caught by the electrical plug, resulting in a spark.There was no death, injury or device malfunction.Neither the tether nor the suction regulator were damaged.The user facility has decided using the suction regulator tether model 9143 and has had our representative remove them from their suction regulators.The user facility has stated that they believe the suction regulator tethers do not conform to the nfpa (b)(4): health care facilities code.Boehringer laboratories has been in communication with the user facility regarding the above and has reviewed the nfpa (b)(4) code.While boehringer laboratories respects the opinion of the user facility/customer, we do not find that the model 9143 tether violates nfpa (b)(4).Since there was no death, injury or malfunction, this voluntary form is being used in lieu of a mandatory report, as provided for in section of the form instructions for fda 3500a.Ref uf report # (b)(4).

• Brand Name: BOEHRINGER LOCKING CABLE
• Common Device Name: SUCTION REGULATOR TETHER
• Manufacturer (Section D): BOEHRINGER LABORATORIES; 300 thomas rd.; phoenixville PA
• MDR Report Key: 6838539
• Report Number: MW5071898
• Device Sequence Number: 460849
• Product Code: KDP
• UDI-Device Identifier: 10816286020543
• UDI-Public: 10816286020543
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date (Section B): 03/08/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9143
• Device Catalogue Number: 9143
• Device Lot Number: NONE
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1