MAUDE Adverse Event Report: C. R. BARD, INC. SILICONE ROUND DRAIN; APPARATUS, SUCTION, SINGLE, PATIENT USE, PORTABLE, NONPOWERED

Model Number 0070310

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/03/2019

Event Type  malfunction  

Event Description

Piece of silicone round drain broke off in pt's knee when pulled.Fda safety report id # (b)(4).

• Brand Name: SILICONE ROUND DRAIN
• Type of Device: APPARATUS, SUCTION, SINGLE, PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 8777150
• MDR Text Key: 150809846
• Report Number: MW5088006
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• 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: 07/08/2019

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 Expiration Date: 12/31/2023
• Device Model Number: 0070310
• Device Lot Number: NGCZ1325
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/09/2019
• 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: 76 YR
• Patient Weight: 53