MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. MINI-SPIKE®; SET, I.V. FLUID TRANSFER

Model Number	412012
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).Although it was confirmed that the device involved is not available for evaluation, 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 after drawing up propofol into a syringe using b.Braun 412012 dispensing pin, small blue particles were seen floating in the propofol.No injury reported.
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for further evaluation.One (1) photo was provided and based on the evaluation results, the reported defect was not confirmed.Visual evaluation of the photo showed the blue cap of the mini-spike dispensing pin, and two other manufacturers blue components along with a partial syringe on a white padding.Also a small blue shaving was observed on the padding.The photo was evaluated and cannot definitively confirm the reported defect was from a b braun manufactured component.House retain samples were inspected, and no foreign matter or contamination was observed.The house retains met specifications.In addition, 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 a sample and/or any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: MINI-SPIKE®
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 9457822
• Report Number: 2523676-2019-00230
• Device Sequence Number: 16912199
• Product Code: LHI
• UDI-Device Identifier: 04022495769671
• UDI-Public: 04022495769671
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K925401
• 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): 01/31/2020

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: 09/30/2024
• Device Model Number: 412012
• Device Catalogue Number: 412012
• Device Lot Number: 0061696178
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/21/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1