MAUDE Adverse Event Report: BARD / C. R. BARD, INC. CWS 400 CLOSED WOUND SUCTION KIT; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number 0043630

Device Problems Material Fragmentation (1261); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device Contamination with Chemical or Other Material (2944); Physical Resistance/Sticking (4012)

Patient Problems Failure of Implant (1924); Device Embedded In Tissue or Plaque (3165)

Event Date 06/25/2020

Event Type  Injury  

Event Description

Received notification from patient care tech that patient's drain had become disconnected from patient.Drain was now contaminated and needed to be d/cd from patient's right knee.Upon initial attempt to pull drain, resistance was met.Multiple attempts were made to bend and straighten the knee due to drain potentially caught on the new knee implant.Multiple angles also attempted to d/c drain without incident.Called resource rn for additional assistance with manipulating the leg to d/c the drain.When drain d/cd, there was a pop-like motion, a jagged tip was seen, and 6 eyelets were visualized.Md was notified for x-ray order, x-ray showed the fragment in the knee; and the patient was taken back to surgery for removal of the drain tip on (b)(6) 2020.Fda safety report id# (b)(4).

• Brand Name: CWS 400 CLOSED WOUND SUCTION KIT
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): BARD / C. R. BARD, INC. ; covington GA 30014
• MDR Report Key: 10223876
• MDR Text Key: 197564606
• Report Number: MW5095332
• 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: 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 0043630
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2020
• 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: 67 YR
• Patient Weight: 116