MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSOMAT®; SET, ADMINISTRATION, INTRA

Model Number 490102

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Type  malfunction  

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.

Event Description

As reported by the user facility: event 17: that the green clip is on the wrong side and it will not load into the pumps.No injury reported.

Manufacturer Narrative

Event 17: this report has been identified as b.Braun medical internal report number (b)(4).Eighteen samples 10 used without packaging and 8 unused in unopened packaging were returned by the facility for evaluation.The 18 samples provided were all visually evaluated and it was noted all 18 samples had an inverted space pump.The reported defect is confirmed.Incidents of this nature are attributed to operator oversight during the assembly of the product.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.As a result of this occurrence, a formal awareness training session was conducted with all applicable personnel involved in the assembly and inspection of this product.The purpose of this training was to review the reported incident and to ensure all personnel understand and comply with the established assembly and inspection processes.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.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: INFUSOMAT®
• Type of Device: SET, ADMINISTRATION, INTRA
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer (Section G): B. BRAUN DOMINICIAN REPULIC INC.; las americas industrial park; km22 autopista las americas; santo domingo ; DR
• Manufacturer Contact: jonathan severino ; 901 marcon blvd.; allentown, PA 18109 ; 4847197287
• MDR Report Key: 15217831
• MDR Text Key: 302838373
• Report Number: 2523676-2022-00413
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964186127
• UDI-Public: (01)04046964186127
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142036
• 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: 09/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 490102
• Device Catalogue Number: 490102
• Device Lot Number: 0061822587
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2022
• 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