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

Lot Number NGFP3613

Device Problems Difficult to Remove (1528); Component Missing (2306)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/20/2021

Event Type  malfunction  

Event Description

Left hip j/p drain removed by md.Upon inspection, the j/p tip was missing, thus retained in the patient.Fda safety report id # (b)(4).

• Brand Name: BARD CLOSED WOUND SUCTION KIT
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): C.R. BARD, INC. ; covington GA 30014
• MDR Report Key: 12307549
• MDR Text Key: 266302376
• Report Number: MW5103157
• Device Sequence Number: 1
• Product Code: GCY
• 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: 08/08/2021

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
• Device Lot Number: NGFP3613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2021
• 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