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

Model Number	415021
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 device involved has not been received for evaluation and 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: it was reported that upon opening the filter straw to draw up furosemide, a white powder debris was noticed in the tube.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Two (2) unused filter straws with packaging were returned for evaluation.One picture was also supplied by the customer.The returned samples were visually evaluated per specification.In one of the filter straws, white powder like material was observed inside the tubing.White particulate was also observed in the second filter straw.The particulate was measured per the tappi chart and the particulate measured 0.2 square mm.In an attempt to identify the defect, this sample was sent to the analytical lab; however, the sample size was not large enough to get a conclusive analysis.The house retain samples were visually evaluated per specification for any foreign material inside or outside the filter straw and no defects were noted.A 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.In addition, review of the batch history records was also performed for the reported lot number and no non-conformances or deviations were noted during the manufacturing process or final inspections.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 STRAW
• Common Device Name: NEEDLE, ASPIRATION AND INJ
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 9810566
• Report Number: 2523676-2020-00069
• Device Sequence Number: 643016
• Product Code: GAA
• UDI-Device Identifier: 04022495284129
• UDI-Public: 04022495284129
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 04/28/2020

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: 02/28/2023
• Device Model Number: 415021
• Device Catalogue Number: 415021
• Device Lot Number: 0061611397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Initial Date Received by Manufacturer: 02/27/2020
• Supplement Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1