MAUDE Adverse Event Report: TELEFLEX-VIDACARE ARROW EZ-10 INRAOSSEOUS VASCULAR ACCESS POWER DRILL; MOTOR SURGICAL INSTRUMENT AC POWERED

Device Problems Failure to Advance (2524); Intermittent Loss of Power (4016)

Patient Problem Laceration(s) (1946)

Event Date 06/15/2018

Event Type  malfunction  

Event Description

The pt presented to the ed with hypotension and tachycardia with difficult iv access.Io needle insertion was attempted by the physician assistant and physician.They attempted to insert the io needle in the tibial tuberosity.The io would not advance into the bone causing a laceration.The physician stated that the drill did not have enough power and on the second attempt, it would stop intermittently.The laceration was repaired with 5 mins.

• Brand Name: ARROW EZ-10 INRAOSSEOUS VASCULAR ACCESS POWER DRILL
• Type of Device: MOTOR SURGICAL INSTRUMENT AC POWERED
• Manufacturer (Section D): TELEFLEX-VIDACARE; research triangle park NC 27709
• MDR Report Key: 7717933
• MDR Text Key: 115189895
• Report Number: MW5078584
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/19/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2018
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR