MAUDE Adverse Event Report: TELEFLEX INCORPORATED LMA; PUMP, INFUSION, ELASTOMERIC

Model Number IPN046570

Device Problems Leak/Splash (1354); Split (2537)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/16/2017

Event Type  malfunction  

Event Description

The pump was retrieved from the pyxis to be used on a patient.After retrieval, the internal bladder holding the medication split open and medication leaked from the bladder.The pump was ordered for a patient but never used on the patient.

• Brand Name: LMA
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): TELEFLEX INCORPORATED; 2917 weck drive; research triangle park NC 27709
• MDR Report Key: 6587298
• MDR Text Key: 75856031
• Report Number: 6587298
• Device Sequence Number: 1
• Product Code: MEB
• 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: Other
• Type of Report: Initial
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/30/2018
• Device Model Number: IPN046570
• Device Catalogue Number: MVBXL-CPNB
• Device Lot Number: 74J1600429
• Other Device ID Number: A150731-PSCFB000US
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/18/2017
• Device Age: 1 DY
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/18/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1