MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. MULTI-AD®; DISPENSER, LIQUID MEDICATI

Model Number 513506

Device Problem Contamination /Decontamination Problem (2895)

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

Event Type  malfunction  

Event Description

As reported by the user facility: event 1: inside the syringe there is a jell-like substance.No injury reported.

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.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).Six samples were sent back for evaluation 3 unopened original packages, 2 un-contaminated without packaging, and 1 sample in an opened package.Two pictures have been provided for this investigation.Two pictures received were visually evaluated per specification for foreign material non-fluid path, it was noted inside the syringe a ring of substance.All six samples were visually evaluated per specification, one sample presented the ring of silicone inside the syringe.5 samples passed visual inspection.Incidents of this nature are attributed to operator oversight during the inspection process of the product for excess silicone.Although our training procedures ensure that all employees are properly trained in their areas of responsibility, an oversight on the part of the operator can attribute to an incident of this nature.An approved project is in place to address issues of this nature.Retained units were evaluated and passed the internal testing.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.Additionally, 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 any additional pertinent information becomes available, a follow up will be submitted.

• Brand Name: MULTI-AD®
• Type of Device: DISPENSER, LIQUID MEDICATI
• 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: 16223802
• MDR Text Key: 308953230
• Report Number: 2523676-2023-00011
• Device Sequence Number: 1
• Product Code: KYX
• UDI-Device Identifier: 04022495770394
• UDI-Public: (01)04022495770394
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K792227
• 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,Followup
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 513506
• Device Catalogue Number: 513506
• Device Lot Number: 0061828409
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1