MAUDE Adverse Event Report: BARD JACKSON PRATT DRAIN; JACKSON - PRATT DRAIN

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

Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)

Event Date 12/11/2015

Event Type  Injury  

Event Description

Pt had a jackson pratt drain in from a lumbar fusion.Dr wrote order to d/c drain, while being removed the white end broke off leaving a part of the drain in the pt, surgical procedure required to remove the remainder for the drain, initial incision has to be partially reopened.

• Brand Name: JACKSON PRATT DRAIN
• Type of Device: JACKSON - PRATT DRAIN
• Manufacturer (Section D): BARD
• MDR Report Key: 5445267
• MDR Text Key: 38529630
• Report Number: MW5060273
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2016

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: No Information
• Other Device ID Number: 7MM FLAT DRAIN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 107