MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG EASYPUMP; PUMP, INFUSION, ELASTOMERI

Model Number 4540018-02

Device Problem Leak/Splash (1354)

Patient Problem Chemical Exposure (2570)

Event Date 02/24/2023

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number 400591349.The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Event Description

As reported by the user facility: detailed inquiry description: chemo leaked from easypump at connection between bottom port and tubing.No injury reported, but chemo exposure to pharmacy technicians reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One used sample wihtout packaging was provided for evaluation.The sample was leaked tested and failed.Incidents of this nature are due to failure in the production process.An approved project is in place to further address issues with leakage.A review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: EASYPUMP
• Type of Device: PUMP, INFUSION, ELASTOMERI
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer (Section G): B. BRAUN MELSUNGEN AG; carl-braun strabe 1; melsungen, 34212 ; GM 34212
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16531467
• MDR Text Key: 311334514
• Report Number: 9610825-2023-00087
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 04046964448638
• UDI-Public: (01)04046964448638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4540018-02
• Device Catalogue Number: 4540018-02
• Device Lot Number: 22F26GE561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1