MAUDE Adverse Event Report: BARD MEDICAL DIVISION JP DRAIN; SILICONE BULB EVACUATOR

Model Number 0071440

Device Problems Break (1069); Structural Problem (2506)

Patient Problems Foreign Body Sensation in Eye (1869); Pain (1994); Discomfort (2330)

Event Date 05/16/2019

Event Type  Injury  

Event Description

Physician attempted to remove jp drain while pt was in icu.Drain broke apart, leaving a piece of drain embedded in pt.Pt had to go to operating room for broken drain removal.

• Brand Name: JP DRAIN
• Type of Device: SILICONE BULB EVACUATOR
• Manufacturer (Section D): BARD MEDICAL DIVISION ; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8771654
• MDR Text Key: 150557562
• Report Number: 8771654
• 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: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/21/2019,06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 0071440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/16/2019
• Device Age: 1 WK
• Event Location: Hospital
• 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): Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 62