MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC DRAIN JACKSON/PRATT RESERVOIR 100CC; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number 130-1305

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/13/2022

Event Type  Injury  

Event Description

Jp (jackson-pratt) drain was placed on (b)(6) 2022 and removed on (b)(6) 2022.During the removal process, drain snapped and broke the tubing.A small piece of drainage end was left in the patient.It may require a procedure to remove the fragment when patient is stable.Fda safety report id# (b)(4).

• Brand Name: DRAIN JACKSON/PRATT RESERVOIR 100CC
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 15638544
• MDR Text Key: 302196974
• Report Number: MW5112753
• 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: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 130-1305
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male