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

Model Number 490102

Device Problem Leak/Splash (1354)

Patient Problem Pain (1994)

Event Date 06/12/2023

Event Type  malfunction  

Event Description

As reported by the user facility: detailed inquiry description: 4901 tubing leak, fluids and blood leaked on floor.Description: iv tubing disconnected at filter site, iv fluids went on floor and blood backed out of iv into tubing and leaked on floor.During conference call with customer on (b)(6)2023, it was mentioned that the patient also felt pain due to lack of medication.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number 400605890.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).One used sample was returned for evaluation.The sample was visually evaluated, and it was noted the backcheck valve was loose and not completely welded.A probable root cause of this defect is that the manufacturing process could have been interrupted during the activation of the sonic weld.Based on the results of the visual evaluation of the sample, the reported defect was confirmed.Exact root cause cannot be determined at this time, but user mishandling cannot be ruled out at this time.It is possible that excessive force on the part would lead to leakage.Since the lot information could not be provided for this incident, a batch record review and a historical review of the customer complaint database could not be performed.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: 17214087
• MDR Text Key: 318234982
• Report Number: 2523676-2023-00306
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2023
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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