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

Model Number 363430

Device Problem Leak/Splash (1354)

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888)

Event Type  Injury  

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 1: detailed inquiry description: set fell apart at the lower injection port.The patient bled to the point where the hemoglobin was too low and required a blood transfusion.

Manufacturer Narrative

This report has been identified as b.Braun medical internal report number (b)(4).One used sample in open packaging was returned for evaluation.The sample was visually evaluated and noted that the most proximal y-caresite valve was detached from the tubing and patient connector from the bonded joint.Under magnification, it was noted the tubing showed an insufficient amount of solvent on the tubing.Based on the evaluation results, the reported defect of detachment was confirmed.An approved project is in place to address the issues of disconnection at bonded joint.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.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: 17162156
• MDR Text Key: 317460920
• Report Number: 2523676-2023-00292
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964294679
• UDI-Public: (01)04046964294679
• 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: 07/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 363430
• Device Catalogue Number: 363430
• Device Lot Number: 0061870726
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2023
• Initial Date FDA Received: 06/20/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2023
• 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
• Patient Outcome(s): Other