MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. APEX®; COMPOUNDER

Device Problem Application Program Problem: Dose Calculation Error (1189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2023

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical, inc.Internal report number (b)(4).The complaint is under evaluation.A follow-up report will be provided after the examination results are available.

Event Description

As reported by the user facility: brief inquiry description: incorrect national drug code (ndc) in delivery factor development.Detailed inquiry description: customer requested delivery factors (df) for a heparin dilution compounded at their facility.The product sent to the b.Braun medical inc.(bbmi) carrolton facility was labeled as heparin in 0.45% normal saline (ns) (b)(4) units per milliliter (units/ml).The heparin dilution was compounded using ndc 63323-276-01, a conventionally manufactured heparin sodium (b)(4) units/2 ml ((b)(4) units/ml).The df request identified the heparin solution as ndc 63323-276-01 which was the same as the ndc noted on the df barcode sheet.However, the apex compounding systems uses ndcs to identify solutions and determine dfs.Without a unique ndc, the apex system would not be able to distinguish between concentrated conventionally manufactured solutions and the customer's heparin dilutions.

• Brand Name: APEX®
• Type of Device: COMPOUNDER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 1601 wallace drive; suite 150; carollton TX 75006 6690
• Manufacturer (Section G): B. BRAUN MEDICAL INC.; 1601 wallace drive; suite 150; carollton TX 75006 6690
• Manufacturer Contact: jonathan severino ; 861 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 18268724
• MDR Text Key: 330668140
• Report Number: 2523676-2023-00750
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1