MAUDE Adverse Event Report: DMS HOLDINGS/BRIGGS MEDICAL SERVICE CO. MEDIC KIT 5; MABIS MEDIC KIT 5

Model Number MEDIC KIT 5

Device Problems Air Leak (1008); Defective Device (2588); Device-Device Incompatibility (2919)

Patient Problem No Patient Involvement (2645)

Event Type  Injury  

Event Description

Medic kit 5 (blood pressure) including mabis branded "caliber" sphygmomanometer, threaded connectors, and reusable blood pressure is unusable due to air leaks at female threaded connector of sphygmomanometer and male threaded connectors of cuff tubing.This was detected during routine pre-use testing; there was no pt involvement with the device failure six kits were received, all were found to be defective.The "caliber" model sphygmomanometer was an unannounced product substitution in the medic kit 5 for the previous and functional "signature" model sphygmomanometer.The threaded screw connectors in the kits with "caliber" sphygmomanometer were also found to leak with both the "signature" and "caliber" branded sphygmomanometer.To a casual or normal observer, the failing threaded connectors appear the same as the functional connectors.Under close examination there are differences in the thread pitch and count of the male connector, and the knurled barrel has a coarser knurled barrel.The air leak that renders the "caliber" medic kit 5 unusable appears to be due to a mismatch between the threaded connectors.

• Brand Name: MEDIC KIT 5
• Type of Device: MABIS MEDIC KIT 5
• Manufacturer (Section D): DMS HOLDINGS/BRIGGS MEDICAL SERVICE CO.; waukegan IL 60085
• MDR Report Key: 5360964
• MDR Text Key: 35798723
• Report Number: MW5059246
• Device Sequence Number: 2
• Product Code: DXN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/07/2016
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MEDIC KIT 5
• Is the Reporter a Health Professional?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention