MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSOMAT; SET, ADMINISTRATION, INTRA

Model Number	363032
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/26/2020
Type of Reportable Event	Malfunction
Additional 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.It should be noted that a possible lot number (0061712062) was provided; however, the lot number does not exist for the reported material number.
Event or Problem Description
As reported by the user facility: customer reports a white piece of plastic within the tubing was obstructing the fluid path of the tubing.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No photos or videos were provided for evaluation.During our investigation into this event, the drawing of item 363032 was consulted for evaluation.It was determined that the small piece was most likely the flow restrictor.This component is intended to be on the set.As no photos or videos were provided, the definitive root cause is unable to be determined at this time.Review of the discrepancy management system (dsms) database performed for the reported lot number revealed no abnormalities or non-conformances noted during in process or final product inspection.

• Brand Name: INFUSOMAT
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 10199471
• Report Number: 2523676-2020-00179
• Device Sequence Number: 16405369
• Product Code: FPA
• UDI-Device Identifier: 04046964294297
• UDI-Public: 04046964294297
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142036
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2020

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: 363032
• Device Catalogue Number: 363032
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/10/2020
• Supplement Date Received by Manufacturer: 06/10/2020
• Initial Report FDA Received Date: 06/26/2020
• Supplement Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1