MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. DISC FILTER; SYRINGE, PISTON

Model Number	415002
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).The investigation into this reported event is ongoing.A follow-up report will be submitted when the results of the investigation are available.
Event or Problem Description
As reported by user facility: black particles were found inside the 0.2 mcg disk filter.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical inc.Internal report number (b)(4).Photos were provided for evaluation.Based on the information and photos provided, the particulate was determined to be native embedded particulate material that is considered a cosmetic defect not impacting the device function.Review of the device history record performed for the reported lot number did not reveal any abnormalities or non-conformances of this nature.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: DISC FILTER
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 200 boulder drive; breinigsville, pa
• MDR Report Key: 9954636
• Report Number: 2532083-2020-00001
• Device Sequence Number: 19530440
• Product Code: FMF
• UDI-Device Identifier: 04022495769770
• UDI-Public: (01)04022495769770
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K941589
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2020

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: 03/31/2022
• Device Model Number: 415002
• Device Catalogue Number: 415002
• Device Lot Number: 13354926
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 04/13/2020
• Supplement Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1