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

Model Number	415072
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: end user reports that a brown speck was noted on the hub.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) photo was provided for further evaluation.Visual examination of the photo confirmed a dark foreign particulate on the hub of the vented needle.Incidents of this nature are attributed to operator oversight during the inspection and 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.A historical review of the customer complaint database dating back one year revealed no trends of this nature against this finished good item or lot number.Therefore, no formal corrective action is warranted at this time.However, all available information regarding this occurrence has been forwarded to the appropriate manufacturing business unit in order to heighten awareness.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: VENTED NEEDLE
• Common Device Name: NEEDLE, ASPIRATION AND INJ
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown, pa
• MDR Report Key: 10055800
• Report Number: 2523676-2020-00130
• Device Sequence Number: 16967242
• Product Code: GAA
• UDI-Device Identifier: 04022495769893
• UDI-Public: 04022495769893
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 06/25/2020

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: 11/30/2024
• Device Model Number: 415072
• Device Catalogue Number: 415072
• Device Lot Number: 0061706964
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 05/14/2020
• Supplement Report FDA Received Date: 06/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1