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

Model Number 4540018-02

Device Problem Leak/Splash (1354)

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

Event Date 06/14/2023

Event Type  malfunction  

Event Description

As reported by the user facility: detailed inquiry description: it looks like the plastic parts on the current 5fu pumps have shown up cracked/cracked while compounding.Unable to give medication due to pump leaking during infusion and set up.No injury reported.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).A total of five (b)(4) samples (four in original packaging and one without original packaging) were submitted to the manufacturer for evaluation.Additionally, the investigation received a 20 ml syringe, 35 ml syringe, 60 ml syringe in original packaging and three original packed luer-lock adapters from the company equashield.A review of the discrepancy management system (dsms) database was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection through visual examination, no damages or other manufacturing faults were observed on the four original packaged samples.The one sample without original packaging was observed to have the inlet taper broken off at the filling port.It is noted that this sample was purposely destroyed by the customer to recreate/illustrate the defect.The provided equashield adaptor was able to fit properly to the filling port of the samples.The samples were then tested with the equasheild adaptor and syringes by proceeding with the filling process to their nominal volume.Upon removal of the adaptor and the syringe, no cracks were observed on the filling port and no leakage was observed on the samples.Please note that this test was unable to be performed on the one sample without original packaging as the filling port was broken.Based on the investigation, the four samples in original packaging are within specification; no damages were observed on the samples and no leakage was observed during testing with the equashield adaptor and syringes.Regarding the one sample without packaging, the damage was created by the customer to recreate the defect as is not due to a failure in the production process.Therefore, the complaint is considered not confirmed.

• 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: 17214097
• MDR Text Key: 318105402
• Report Number: 9610825-2023-00298
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• 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: 22C30GE561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1