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

Catalog Number 4540040-02

Device Problems Degraded (1153); Loose or Intermittent Connection (1371); Component Missing (2306); Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report (b)(4).Event 2 the complaint is still under investigation.A follow-up report will be provided, as soon as investigation has been completed.

Event Description

As reported by user facility: event 2 "i have some easypump defects to report from throughout august that are summarized below, samples are available for all pumps.2 with orange particle in the patient connector.1 with orange particle in the patient connector.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Event 2: 82 samples were returned, with foreign particles in the fluid and non-fluid path.After a visual inspection, the complaints were confirmed.This was deemed to be a failure in the production process.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.

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report (b)(4): event 2 82 samples were returned, with foreign particles in the fluid and non-fluid path.After a visual inspection, the complaints were confirmed.This was deemed to be a failure in the production process.Please note that we are unsure if the follow-ups were originally submitted or received on 08jun2022 and we are resubmitting out of an abundance of caution.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, ELASTOMERIC
• 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 ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 12515768
• MDR Text Key: 272907563
• Report Number: 9610825-2021-00395
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K081905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/05/2023

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: Health Professional
• Device Catalogue Number: 4540040-02
• Device Lot Number: 20L02GE671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2021
• Initial Date FDA Received: 09/22/2021
• Supplement Dates Manufacturer Received: 08/26/2021; 08/26/2021
• Supplement Dates FDA Received: 06/09/2022; 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1