MAUDE Adverse Event Report: JACKSON- PRATT DRAIN; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Device Problem Entrapment of Device (1212)

Patient Problems Laceration(s) (1946); Device Embedded In Tissue or Plaque (3165)

Event Date 11/08/2021

Event Type  Injury  

Event Description

A 19-fr round jackson-pratt (jp) drain was placed behind the kidney prior to closure of the fascia.The patient was discharged home on (b)(6) 2021, in stable condition, with the jp drain in place, with a plan for removal as an outpatient when the output dropped to <10 mls per day.The jp drain was removed during a post-operative clinic visit on (b)(6) 2021.A ct scan completed on (b)(6) 2021 showed a "??" right lower quadrant renal transplant kidney with surrounding retained catheter.The patient was taken to the operating room on (b)(6) 2021, where a piece of jp drain was identified and removed.Fda safety report id # (b)(4).

• Brand Name: JACKSON- PRATT DRAIN
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• MDR Report Key: 13043264
• MDR Text Key: 282577420
• Report Number: MW5106163
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 47 YR
• Patient Sex: Female