MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC JACKSON-PRATT DRAIN 7 MM FLAT FLUTED W/TROCAR; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Catalog Number JP-2212

Device Problems Break (1069); Entrapment of Device (1212); Product Quality Problem (1506)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/30/2023

Event Type  Injury  

Event Description

During removal of jackson pratt 7mm fluted drain from a patient's scalp, the junction between the clear drain tubing and fluted white piece appeared to be severed and emerged from the scalp, leaving the length of the subgaleal portion retained in the wound.This is the 3rd event that this has happened at our institution with the same drain.

• Brand Name: JACKSON-PRATT DRAIN 7 MM FLAT FLUTED W/TROCAR
• Type of Device: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC
• MDR Report Key: 16701464
• MDR Text Key: 313006125
• Report Number: MW5116442
• 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: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: JP-2212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention