BOEHRINGER LOCKING CABLE 9143

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-09-01 for BOEHRINGER LOCKING CABLE 9143 manufactured by Boehringer Laboratories.

Event Text Entries

[84708830] 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).
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5071898
• MDR Report Key: 6838539
• Date Received: 2017-09-01
• Date of Report: 2017-03-08
• Date of Event: 2016-12-09
• Date Added to Maude: 2017-09-01
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: UNKNOWN
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: BOEHRINGER LOCKING CABLE
• Generic Name: SUCTION REGULATOR TETHER
• Product Code: KDP
• Date Received: 2017-09-01
• Model Number: 9143
• Catalog Number: 9143
• Lot Number: NONE
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BOEHRINGER LABORATORIES
• Manufacturer Address: 300 THOMAS RD. PHOENIXVILLE PA US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2017-09-01