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

Model Number	4540040-02
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: 1 x black particle in the closing cone in the patient connector (in the fluid path) (09292022@1) - prior to filling.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number 400598939.The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number cc (b)(4).Bmi complaint management statement:- device history record (dhr):- reviewed the dhr for batch 21n17ge671, there is no abnormality and no such defect detected at in process and at final control inspection.Samples receipt at bmi - complaint management, dated: 2023-05-30.Sample evaluation:- received 1 sample of easypump ii st 100-0,5-s-us without original packaging.The batch number on the big bottom cap of the sample was 21n17ge671.Upon received, no solution was found in the sample and the sample was not clamped.Its filling port was closed with discofix cap, whereas its patient connector was closed with wing cap.By visually checking the sample, foreign material was observed at the patient connector of the sample.Refer to the picture attached in the pc notification.Complaint and sample to be forwarded to production for further investigation.Remarks: refer to other pc created for investigation on other defects.Root cause analysis: sample/s evaluation: received 1 sample without original packaging.There is one contaminant detected at the la-cone.The contaminant was extracted and transfer to one zipper bag.The contaminant was compared with tappi chart and the size of the contaminant is approximately 0.08mm2.According to test specification of elastomeric infusion systems for assembly, hc-my01-m-5-4-10-407-0, in fluid path, one contaminant with the size less than 0.5mm2 is allowed, thus, the sample received is still within specification.However, capa 280262 had been raised to address general loose contamination and hair issue.Summary of root cause analysis: the sample received is still within specification.Hence, we considered this complaint as not confirmed.However, capa 280262 had been raised to address general loose contamination and hair issue.

• Brand Name: EASYPUMP
• Common Device Name: 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: 16898029
• Report Number: 9610825-2023-00215
• Device Sequence Number: 17507486
• Product Code: MEB
• UDI-Device Identifier: 04046964448942
• UDI-Public: (01)04046964448942
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081905
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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
• Operator of Device: Health Professional
• Device Model Number: 4540040-02
• Device Catalogue Number: 4540040-02
• Device Lot Number: 21N17GE671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown