MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. FILTER NEEDLE; NEEDLE, ASPIRATION AND INJ

Model Number	415040
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as (b)(6) 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: customer reports that there is what appears to be black mold on the inside of the needle cover.No injury report.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One unused sample in opened packaging identifying the reported number was returned for evaluation.Visual evaluation of the sample showed various dark embedded specs identified as burnt resin (die drool) in the guard, which is caused during the molding process.Visual evaluation of the returned sample confirmed the foreign contamination to be burnt resin.Incidents of this nature are attributed to operator oversight during the manufacturing/packaging of the product.Although our training procedures ensure that all of our employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.As a result of this occurrence, a new work instruction was created for 100% inspection for black particulates during manufacturing and packaging for this product.All applicable personnel involved in the assembly and inspection of this product will be trained to review the reported incident and to ensure all personnel understand and comply with the established assembly and inspection processes.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.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: FILTER NEEDLE
• Common Device Name: NEEDLE, ASPIRATION AND INJ
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 11527011
• Report Number: 2523676-2021-00065
• Device Sequence Number: 5170047
• Product Code: GAA
• UDI-Device Identifier: 04022495769824
• UDI-Public: 04022495769824
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 04/29/2021

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: 10/31/2025
• Device Model Number: 415040
• Device Catalogue Number: 415040
• Device Lot Number: 0061755571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 03/19/2021
• Supplement Report FDA Received Date: 04/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1