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 Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This report has been identified as b.Braun medical internal report number (b)(4).No sample was provided for evaluation.Based on the data from the investigation we are unable to determine the root cause of the reported incident.The reported defect was unable to be confirmed.The actual defective device is a valuable tool in investigating the cause of this incident.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.
Event or Problem Description
As per medwatch it was reported: description: we have had multiple event reports of pharmacists noting particulate in daptomycin preparations with the daptomycin for injection 500mg/vial xellia pharmaceuticals ndc 70594-034-01 product.With further investigation it appears this was not limited to a certain individual who was compounding and occurred multiple dates and times with, various lot numbers at different sites across our health system.The manufacture notes need to use certain products to compound this product including a 21g needle which is smaller than standard needles used for compounding or a vented needle from bbraun (ref 415072).Our site has used both devices a 21g needle and the vented needle recommended by the manufacture with continued concerns of coring reported visible to the eye.Luckily these have been near miss events caught by our pharmacist prior to reaching the patients with no harm noted to patients, however, is still of concern.We have alerted the manufacture and they noted they did not find any internal issues with the product given the consistent concerns we now have the technicians filter this product at our site prior to dispensing.No injury reported.

• Brand Name: VENTED NEEDLE
• Common Device Name: NEEDLE, ASPIRATION AND INJ
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 16751147
• Report Number: 2523676-2023-00095
• Device Sequence Number: 3429411
• Product Code: GAA
• UDI-Device Identifier: 04022495769893
• UDI-Public: (01)04022495769893
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/17/2023

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 Model Number: 415072
• Device Catalogue Number: 415072
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2023
• Initial Report FDA Received Date: 04/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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