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

Model Number 490100

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Type  malfunction  

Event Description

As reported by the user facility: detailed inquiry description rn clamped the iv tubing connected to the patient to administer zofran iv push but when she disconnected the tubing from the patient, the tubing broke off into the adaptor causing backflow of blood from iv site onto rn and patient.Patient is known hiv positive.

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).Two (2) samples with no packaging were returned for evaluation.The samples were visually evaluated, and it was noted that 1 out 2 samples were confirmed to have the patient connector broken off inside a straight body caresite valve.Unfortunately, due to contamination reasons both samples needed to be scrapped because of possible hiv-positive blood found to be in sets.Based on the evaluation results, the patient connector was broken off inside the y-care site.Although the exact root cause cannot be determined, previous engineering testing cited a probable root cause could be alcohol exposure of certain male adapters, which can lead to difficulty removing or breakage of male luer tapers when connected to female luers.Per the ifu it states, "swab top lad vigorously for 15 seconds with 70% isopropyl alcohol and allow to air dry prior to use." 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: 14850807
• MDR Text Key: 303239394
• Report Number: 2523676-2022-00337
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 04046964186080
• UDI-Public: (01)04046964186080
• 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: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 490100
• Device Catalogue Number: 490100
• Device Lot Number: 0061826193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2022
• 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