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

Catalog Number	412012
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
As reported by the user facility: during 100% black/white box visual inspection on (b)(6) 2023 pharmacist found one bag to have a white floating particle inside.Drug had been added to the bag.Per batch record instruction the mini spike is changed about every 20 spikes.We tested a few spikes into the stopper after compounding and did notice visible markings on the spike after withdrawal from the vial.No injury reported.
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.
Additional Manufacturer Narrative
One (1) used sample without packaging was returned for investigation.Additionally, four (4) photographs were returned for evaluation.The returned photographs were subject to a visual evaluation.Photographs #1 and #4 provided information identifying a drug vial with no conclusions to be made.Photograph #2 is identified as a dispensing pin with no defect able to be identified.In photograph #3 a white particulate was observed on top of the drug vial.The exact determination of where this particulate came from cannot be concluded.The returned sample was subjected to a visual examination.No foreign matter or product coring is located on the dispensing pin.The sample was spiked multiple times into a vial with no abnormalities detected.Although no defect was able to be identified on the physical sample, through evaluation of the photograph the white particulate can be seen and therefore the defect is 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.No defect can be concluded on the sample returned from the customer however white particulate can be identified in the picture provided.The exact root cause cannot be determined at this time.

• 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
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18147685
• Report Number: 2523676-2023-00739
• Device Sequence Number: 15329282
• Product Code: LHI
• UDI-Device Identifier: 04022495769671
• UDI-Public: (01)04022495769671
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K925401
• 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 Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2024

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 Catalogue Number: 412012
• Device Lot Number: 0061841928
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2023
• Supplement Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown