MAUDE Adverse Event Report: C. R. BARD, INC. BARD EVACUATOR KIT; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number 0043610

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/03/2021

Event Type  Injury  

Event Description

Bard evacuator kit hemovac was removed from patient's left thigh wound on (b)(6) 2021 and it was immediately noted by removing physician that the tip of the suction tubing was missing.An x-ray was taken which confirmed that the tip of the suction tubing was in the wound.The patient required an i&d five days later (not due to the device tip in the wound) and the tip was removed at that time.Fda safety report id # (b)(4).

• Brand Name: BARD EVACUATOR KIT
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 11737335
• MDR Text Key: 248152492
• Report Number: MW5101020
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0043610
• Device Catalogue Number: 0043610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 112