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

Model Number	470117
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.
Event or Problem Description
As reported by the user facility: event 1: the end user found a black particulate in the filtered extension set.No injury reported.
Additional Manufacturer Narrative
This report has been identified as event 1 of b.Braun medical internal report number (b)(4).One (1) photo was provided for evaluation.The returned photo was visually evaluated per specification, and residue was unable to be identified.It was also reported by the end customer that the filter had not been changed over until a prolonged time of 24 hours.Therefore, this defect was determined to not have been due to a manufacturing issue.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: CARESITE
• Common Device Name: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 10055795
• Report Number: 2523676-2020-00131
• Device Sequence Number: 3292841
• Product Code: FPA
• UDI-Device Identifier: 04046964183997
• UDI-Public: 04046964183997
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K942988
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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 Expiration Date: 10/23/2022
• Device Model Number: 470117
• Device Catalogue Number: 470117
• Device Lot Number: 0061701219
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/28/2020
• Supplement Date Received by Manufacturer: 04/28/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1