MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. FLUID DISPENSING CONNECTOR; DISPENSER, LIQUID MEDICATI

Catalog Number	415080
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 the pharmacy technician noted a black substance on the green tip of the fluid dispensing connector as soon as the product was removed from the packaging.No patient involvement.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).One (1) fluid dispensing connector without packaging was returned by customer for evaluation.A picture was also provided by the customer.The dispensing connector and a picture were visually evaluated per specifications.It was noted to have black substance on the connector.The reported defect has been confirmed.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.The house retains were visually evaluated per specifications.No defect was noted on the connectors.While we are unable to confirm the specific nature of the reported defect, we will maintain this report for further references and continue to monitor other reports for similar occurrences.If a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: FLUID DISPENSING CONNECTOR
• Common Device Name: DISPENSER, LIQUID MEDICATI
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 8980190
• Report Number: 2523676-2019-00154
• Device Sequence Number: 2568022
• Product Code: KYX
• UDI-Device Identifier: 04022495820105
• UDI-Public: 04022495820105
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K800437
• 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): 09/30/2019

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: 12/31/2023
• Device Catalogue Number: 415080
• Device Lot Number: 0061657808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2019
• Initial Date Received by Manufacturer: 08/15/2019
• Supplement Date Received by Manufacturer: 08/15/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1